# Launching a Medical Device in the U.S. in 2026

## TL;DR

Before releasing a first U.S. shipment, match the marketed product to its FDA pathway, retain the evidence for it, assign each registration and importer duty, and give the customs broker an entry record that matches those filings [1](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-1) [2](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-2). The workpaper compares an intermittent clinical infrared thermometer that qualifies for a conditional 510(k) exemption with a digital blood pressure monitor that requires clearance [3](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-3) [4](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-4).

For FY2027, the foreign manufacturer and a separate initial importer each pay a $13,785 establishment registration fee [5](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-5). The blood pressure monitor adds the $28,653 standard 510(k) fee [5](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-5). Non-U.S. Traditional 510(k)s cleared from 2021 through October 30, 2026 took a median of 159 calendar days from FDA receipt to decision [6](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-6). The exempt entry omits the premarket number. The cleared entry carries the number on the device listing [1](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-1) [7](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-7). Submit each known importer and each party used to facilitate import to FDA through the registration and listing system, as required by 21 CFR 807.41 [8](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-8).

* * *

## Hypothetical Manufacturer Profile and the Classification-Exemption Boundary

To examine regulatory handoffs, entity assignments, quality audit triggers, and customs message segments in operational context, this workpaper follows an illustrative non-U.S. medical device manufacturer—Suzhou VeloMed Instruments Co., Ltd. (VeloMed, a hypothetical Chinese manufacturer holding ISO 13485 certification and lacking a U.S. physical subsidiary)—beginning a two-product U.S. launch in late 2026:

1.  Product A (_VeloTemp IR-200_, Class II): An intermittent clinical infrared thermometer classified under 21 CFR 880.2910, product code SDV [9](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-9). The 510(k) exemption depends on the three conditions in § 880.2910(b) and the limits in § 880.9, set out below [3](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-3) [10](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-10).
2.  Product B (_VeloPress BP-400_, Class II): An automated noninvasive upper-arm blood pressure monitor incorporating Bluetooth telemetry, classified under 21 CFR 870.1130, product code DXN, requiring 510(k) clearance [11](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-11). This workpaper assumes a Traditional 510(k).

Both worked devices are Class II. The QMSR section below explains the design controls that apply to both.

CDRH Device Classification Inventory by Risk Class and Premarket Review Pathway (n = 6,564 Classified Codes of 7,084 Total)Across 7,084 FDA classification product codes (6,564 classified under Class I, II, or III), device risk class does not determine premarket pathway. In Class I, 155 of 2,401 product codes (6.5%) still require a 510(k) clearance, whereas in Class II, 484 of 3,632 codes (13.3%) are 510(k)-exempt subject to 21 CFR 8xx.9 limitations and product-specific conditions. Class III comprises 500 PMA, 4 HDE, and 27 other premarket codes. The extract records 520 other codes outside Classes I, II and III: 383 N, 86 U and 51 f.Product Codes
|  | 510(k)-Exempt | 510(k)-Required | Enforcement Discretion / Other | PMA / HDE |
| --- | --- | --- | --- | --- |
| Class I | 2,154 | 155 | 92 | 0 |
| Class II | 484 | 2,992 | 156 | 0 |
| Class III | 0 | 0 | 27 | 504 |

Source: FDA CDRH Product Classification Database (snapshot August 24, 2026); Pure Global analysis, accessed August 2026

Across the 7,084 total product codes in FDA's CDRH Product Classification database (including 6,564 classified under Class I, II, or III), premarket submission requirements vary within each device risk class [12](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-12):

-   Class I devices (2,401 product codes): While 2,154 codes (89.7%) are 510(k)-exempt and 92 (3.8%) fall under enforcement discretion or special contact status, 155 Class I product codes (6.5%) still require a 510(k) clearance [12](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-12). These non-exempt Class I codes include patient examination gloves (Latex Patient Examination Gloves, product code LYY, and Polymer Patient Examination Gloves, product code LZA, under 21 CFR 880.6250), alongside 53 microbiology codes and 23 clinical chemistry codes [12](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-12).
-   Class II devices (3,632 product codes): Standard 510(k) review applies to 2,992 codes (82.4%), enforcement discretion or other premarket status covers 156 codes (4.3%), and 484 Class II codes (13.3%) qualify as 510(k)-exempt subject to general and regulation-specific limitations [12](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-12). Exempt Class II codes cluster in microbiology (61), gastroenterology and urology (56), clinical chemistry (44), hematology (44), general hospital (32, including VeloMed's SDV), radiology (32), physical medicine (27), and general and plastic surgery (24) [12](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-12).
-   Class III and unclassified categories: Class III encompasses 531 product codes (500 PMA, 4 Humanitarian Device Exemption (HDE), and 27 other premarket categories) [12](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-12). The extract records 520 additional codes outside Classes I, II and III: 383 N, 86 U (66 requiring 510(k)), and 51 f [12](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-12).

### How 21 CFR 8xx.9 and Marketing Claims Limit Exemptions

A 510(k)-exempt product code listing provides conditional exemption rather than permanent immunity. Under 21 CFR 880.9 (and corresponding sections across 21 CFR Parts 862 through 892), an exemption applies only to those devices within the generic type that have existing or reasonably foreseeable characteristics of commercially distributed devices [10](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-10). The regulation establishes three explicit limbs where exemption status terminates:

1.  Limb (a) — Different Intended Use: The device has an intended use that is different from the intended use of a legally marketed device in that generic type. The regulation cites as examples a device that has a different medical purpose or is intended for "lay use where the former intended use was by health care professionals only" [10](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-10).
2.  Limb (b) — Different Fundamental Scientific Technology: The device operates using a different fundamental scientific technology than that of a legally marketed device in that generic type. Regulatory examples include a surgical instrument that cuts with a laser beam rather than a sharpened metal blade, or an assay that uses a DNA probe or nucleic acid hybridization rather than culture or immunoassay techniques [10](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-10).
3.  Limb (c) — In Vitro Diagnostic Criteria: The device is an in vitro diagnostic device that is intended for any of the nine listed in vitro diagnostic uses detailed in 21 CFR 880.9(c), including noninvasive testing and near-patient testing [10](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-10).

In our interpretation for connected and software-enabled devices, introducing companion mobile applications, continuous monitoring algorithms, automated diagnostic interpretation, or novel physiological sensor configurations into a previously exempt mechanical or intermittent tool can void exemption status when the changes alter the generic intended use or fundamental technology under Limb (a) or Limb (b).

Product A demonstrates how product-specific exemption conditions intersect these general limits. On June 18, 2025, FDA published a final order (90 FR 25889) amending 21 CFR 880.2910 to exempt clinical electronic thermometers from 510(k) notification, establishing three distinct product codes [3](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-3):

-   Product Code SDV (Clinical Electronic Thermometer): 510(k)-exempt, provided the device satisfies all three conditions of 21 CFR 880.2910(b): no telethermographic functions, no continuous temperature measurement functions, and completed analysis and testing validating specifications and performance (such as ISO 80601-2-56 or ASTM E1965) [9](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-9) [3](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-3).
-   Product Code SDW (Stationary Infrared Thermometer): Non-exempt, covering free-standing or mounted clinical electronic thermometers. A 510(k) is required [3](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-3) [12](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-12).
-   Product Code FLL (Continuous Measurement Thermometer): Non-exempt, covering thermometers indicated to measure body or skin temperature continuously or at specified intervals. A 510(k) is required [3](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-3) [12](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-12).

If VeloMed markets the _VeloTemp IR-200_ with smartphone software for continuous overnight fever tracking, the product no longer meets 21 CFR 880.2910(b)(2); in our reading 21 CFR 880.9(a) may also apply, shifting the product from exempt product code SDV to non-exempt product code FLL [9](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-9) [10](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-10) [3](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-3). If clearance is required, commercial distribution without it may render the device adulterated under FD&C Act § 501(f)(1)(B) and misbranded under § 502(o), and FDA may refuse admission under § 801(a) [13](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-13) [14](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-14).

A June 2026 letter shows FDA applying this limit to website claims. In a Warning Letter dated June 3, 2026 to BlephEx, LLC (CMS 725861), FDA cited the manufacturer after reviewing claims on the firm's website marketing its Powered Eyelid Cleaning Sponge (Class I, 21 CFR 878.4820, product code PYU) for chronic blepharitis and dry eye disease [13](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-13). Although the firm held a formal Section 513(g) response evaluating the device as Class I exempt for eyelid hygiene, FDA concluded the therapeutic disease claims exceeded generic classification limits under 21 CFR 878.9, rendering the device adulterated under Section 501(f)(1)(B) and misbranded under Section 502(o) for lack of a cleared 510(k), while also citing failure to submit UDI data to GUDID [13](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-13).

In FDA's CDRH Recall Enterprise database (August 24, 2026 snapshot), 953 product-level recall records cite "No Marketing Application" as the root cause [15](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-15). These product-level records reflect multi-SKU actions rather than independent device failures; for example, in calendar year 2024 based on recall initiation date, 291 product-level records derived from 12 distinct recall events [15](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-15).

| Classification & Exemption Checkpoints | Product A (_VeloTemp IR-200_, SDV) | Product B (_VeloPress BP-400_, DXN) | Regulatory Basis & Operational Risk |
| --- | --- | --- | --- |
| **FDA Regulation & Risk Class** | 21 CFR 880.2910 (Class II) [9](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-9) | 21 CFR 870.1130 (Class II) [11](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-11) | Regulatory classification dictates premarket and quality requirements |
| **Premarket Pathway Status** | 510(k)-Exempt (conditional under 21 CFR 880.2910(b) and 880.9) [10](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-10) [3](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-3) | 510(k) clearance required [4](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-4). The workpaper assumes a Traditional 510(k). A Special 510(k) is unavailable for a first clearance [16](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-16). FDA marks DXN eligible for third-party review. Determine suitability for that route or an Abbreviated 510(k) for the actual device [12](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-12) | Commercial entry without required clearance may make the device adulterated under FD&C Act § 501(f)(1)(B) and misbranded under § 502(o), with refusal of admission under § 801(a) [13](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-13) [14](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-14) |
| **Classification Boundary Risks** | A thermometer indicated to measure continuously or at specified intervals falls under non-exempt FLL. A telethermographic function fails § 880.2910(b)(1). Free-standing or mounted infrared thermometers fall under non-exempt SDW. Missing required validation also defeats the SDV exemption [3](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-3) [12](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-12) | Firmware, algorithm, or telemetry changes trigger 21 CFR 807.81(a)(3)(i) new 510(k) evaluation [17](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-17) | Exceeding the exemption limits, or distributing a modified device that requires a new 510(k) under § 807.81(a)(3) before obtaining it, leaves the device without required clearance |
| **QMSR Design Controls (21 CFR 820.10(c))** | **Mandatory** (Class II finished device; ISO 13485 Clause 7.3 applies) [18](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-18) | **Mandatory** (Class II finished device; ISO 13485 Clause 7.3 applies) [18](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-18) | 510(k) exemption waives premarket submission only; design controls remain legally binding |
| **Labeling & Promotional Review Scope** | Audit packaging, manuals, and website claims to confirm absence of continuous fever tracking or medical treatment claims | Verify specifications, firmware and indications against the applicable clearance and documented permissible post-clearance changes. Where a new 510(k) is required, obtain clearance before commercial distribution [17](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-17) | In the BlephEx letter FDA relied on commercial claims on the firm's website [13](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-13) |

* * *

## End-to-End 2026–2027 Launch Sequence, Gate Ownership, and Premarket Clocks

Executing a U.S. launch requires foreign regulatory and supply-chain directors to integrate premarket clearance, quality systems, establishment registration, contractual representation, and customs filings into a sequential eight-gate dependency chain. Because Product A is 510(k)-exempt and Product B requires 510(k) clearance, VeloMed operates two synchronized tracks: an exempt track that Pure Global plans at 6 to 10 weeks for registration and first entry once the technical and design files are complete, and a multi-quarter premarket clearance track, converging at establishment registration and customs clearance.

### The 8-Gate Launch Sequence and RACI Matrix

_Key: Deliverables are tagged individually: Regulatory Requirement indicates an obligation established in cited statute or regulations; Recommended Practice indicates Pure Global's operational advisory standard._

| Gate & Focus | Primary Deliverables | Foreign Manufacturer (VeloMed) | U.S. Agent (21 CFR 807.40), or separate consultant where indicated | U.S. Initial Importer | Licensed Customs Broker | Track Alignment: Product A (SDV Exempt) vs. Product B (DXN Cleared) |
| --- | --- | --- | --- | --- | --- | --- |
| **1\. Classification & Claims Lock** | Finalize product code, verify 21 CFR 8xx.9 and 880.2910(b) conditions (_Regulatory Requirement_); evaluate HTSUS lines and freeze U.S. promotional claims (_Recommended Practice_) | **Accountable / Owner** | **Regulatory consultant**, if separately engaged | Informed | Informed (HTSUS verification) | Weeks 1–3 planning assumption (Product A locks intermittent indication and ISO 80601-2-56 data; Product B locks predicate device) |
| **2\. QMSR Technical & Design File** | ISO 13485 Clause 7.1 risk management, Clause 7.3 design and development file, Clause 7.6 control of monitoring and measuring equipment, including its software; electrical safety and biocompatibility evidence where applicable (_Regulatory Requirement_) | **Accountable / Owner** | **Regulatory consultant**, if separately engaged | Informed | — | Weeks 2–14 planning assumption (Product A verifies Class II design file; Product B compiles eSTAR verification data) |
| **3\. MDUFA User Fee Setup & SBD** | Create FDA User Fee account, pay mandatory MDUFA user fees (_Regulatory Requirement_); for the optional reduced submission fee, assess the $100 million threshold including domestic and foreign affiliates and submit the applicable Form FDA 3602N and supporting documents | **Accountable / Owner** | **Coordinator** | Informed | — | Completed prior to 510(k) submission or FURLS registration; FDA review goal for SBD applications is within 60 calendar days of receipt [19](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-19) |
| **4\. Premarket 510(k) Submission** | eSTAR submission via CDRH Portal, automated virus scan, and eSTAR technical screening (_Regulatory Requirement_) | **Owner / Sponsor** | **Regulatory consultant, if separately engaged** | Informed | — | **Product A:** Skipped ($0 fee). **Product B:** Traditional 510(k) calendar duration median 159 days (IQR 91–254 days) [6](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-6) |
| **5\. Contracting U.S. Agent & Importer** | Designate U.S. Agent under 21 CFR 807.40 (_Regulatory Requirement_); execute Importer Quality and Vigilance Agreement under 21 CFR 803.40, 806.10, and 820.35(a) (_Recommended Practice_) | **Accountable** | **Accepts U.S. Agent Designation** | **Executes Importer Quality SLA** | Informed | Agent designation is required for registration; Pure Global recommends executing the importer agreement before dispatch |
| **6\. FURLS Registration, Listing & UDI** | Pay annual establishment fee, obtain FEI/Reg #, create listing (LST), link premarket number (PM#), publish GUDID DI, and identify each known importer with the devices it receives and each facilitating agent or broker under 21 CFR 807.41 (_Regulatory Requirement_) | **Payer / Owner** | **FURLS Submitter / Correspondent** | **Registers and pays own annual fee** | **Receives FEI, Reg #, LST, PM#** | Completed prior to commercial export; registration window opens upon clearance (Product B) or launch readiness (Product A) |
| **7\. Post-Market Intake Readiness** | Implement complaint intake procedures (21 CFR 820.35(a)), electronic MDR gateway accounts (Part 803), and correction/removal SOPs (Part 806) (_Regulatory Requirement_) | **Accountable (CAPA)** | Communications conduit | **Operates U.S. complaint intake** | — | Systems operational and verified before first commercial consignment enters U.S. distribution |
| **8\. Pre-Departure Broker Data Sheet Verification** | Cross-check broker instruction sheet against ACE Supplemental Guide Tables 11-3 to 11-18 and active FURLS records (_Recommended Practice_) | **Issues Instruction Sheet** | Verifies active FURLS status | **Confirms physical U.S. address** | **Reviews Message Set** | Conducted prior to freight tender; ensure all entity roles and affirmation strings match FDA records |

### Empirical 510(k) Review Clocks, eSTAR Technical Screening, and Review Track Tradeoffs

Applicants with non-U.S. addresses received more than half of the FDA 510(k) clearances in each year from 2021 through the October 30, 2026 cutoff. Their share rose from 38.2% (1,120 of 2,930) in 2016 to 53.4% (1,597 of 2,993) in 2021 [6](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-6). The later shares were 53.2% (1,694 of 3,187) in 2022, 50.7% (1,674 of 3,299) in 2023, 51.6% (1,589 of 3,082) in 2024, 52.3% (1,672 of 3,198) in 2025 and 51.4% (1,441 of 2,802) from January 1 through October 30, 2026 [6](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-6).

Annual FDA 510(k) Clearance Share by Applicant Address (2016–2026 YTD)From 2021 onward, non-U.S. addresses accounted for more than half of annual 510(k) clearances through the October 30, 2026 cutoff. The share was 53.4% (1,597 of 2,993) in 2021 and 51.4% (1,441 of 2,802) in 2026 through the cutoff. The pathway cohort contains 18,561 clearances (9,667 non-U.S. and 8,894 U.S.). De Novo grants are excluded.%
|  | Applicants with Non-U.S. Addresses (%) | Applicants with U.S. Addresses (%) |
| --- | --- | --- |
| 2016 | 38.2% | 61.8% |
| 2017 | 39.6% | 60.4% |
| 2018 | 40.3% | 59.7% |
| 2019 | 42.1% | 57.9% |
| 2020 | 43.4% | 56.6% |
| 2021 | 53.4% | 46.6% |
| 2022 | 53.2% | 46.8% |
| 2023 | 50.7% | 49.3% |
| 2024 | 51.6% | 48.4% |
| 2025 | 52.3% | 47.7% |
| 2026 YTD | 51.4% | 48.6% |

Source: FDA CDRH 510(k) Premarket Notification Database (decisions through October 30, 2026); Pure Global analysis, accessed November 2026

Examining all 18,561 clearances from 2021 through October 30, 2026 with country-identified applicant data (9,667 non-U.S. clearances and 8,894 U.S. clearances) illustrates significant variation in total calendar duration across review pathways [6](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-6). Total calendar days measure elapsed time from initial FDA receipt (**date\_received**) to final clearance decision (**decision\_date**), incorporating both active FDA review time and applicant Additional Information (AI) hold periods [6](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-6):

-   Traditional 510(k) (8,440 non-U.S. clearances vs. 7,048 U.S. clearances): Non-U.S. applicants experienced a median total calendar duration of 159 days (interquartile range 91 to 254 days), compared with 146 days for U.S. applicants (interquartile range 90 to 240 days) [6](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-6). The calculation includes all cases in each Traditional group, including those flagged for third-party involvement. The records combine first-time and repeat applicants across product codes. External pre-submission factors, such as electromagnetic compatibility (EMC) and biocompatibility testing, are entirely excluded from these recorded timelines.
-   Special 510(k) (1,064 non-U.S. clearances vs. 1,679 U.S. clearances): FDA’s Special 510(k) Program can cover a design or labeling change to the manufacturer’s own legally marketed device, including certain changes to the indications for use. The route requires either no performance data or well-established methods where data are necessary, and any necessary data must be reviewable in a summary or risk-analysis format [16](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-16). Special 510(k) clearances took a median of 30 days for non-U.S. applicants (interquartile range 28 to 83 days) and 29 days for U.S. applicants (interquartile range 28 to 48 days) [6](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-6). All cases in each Special group contribute to its median. Special submissions represented 1,064 of 9,667 non-U.S. clearances (11.0%) and 1,679 of 8,894 U.S. clearances (18.9%) [6](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-6). Because Special 510(k) eligibility requires modifying the sponsor's own cleared device, this track is not available under FDA's Special 510(k) Program for Product B's initial market clearance [16](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-16).
-   Abbreviated 510(k) (155 non-U.S. clearances vs. 113 U.S. clearances): Non-U.S. submissions demonstrated a median calendar duration of 144 days (interquartile range 92.5 to 239 days), compared with 165 days for U.S. submissions. All cases in each Abbreviated group contribute to its median. The category represented 155 of 9,667 non-U.S. clearances (1.6%) and 113 of 8,894 U.S. clearances (1.3%) [6](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-6).
-   Dual Track accounts for the balance of both totals: 8 non-U.S. and 54 U.S. clearances [6](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-6). See the methodology for the FDA’s use of the Dual Track label.
-   Third-Party 510(k) Review Program (separate flag): Submissions reviewed by accredited Third-Party Review Organizations were cleared by FDA in a median of 29 days from formal FDA receipt for non-U.S. applicants (n = 162), compared with 28 days for U.S. applicants (n = 214) [6](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-6) [20](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-20). Under this program, accredited commercial organizations conduct the primary review and submit a recommendation, after which FDA makes the final clearance decision [20](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-20). The recorded 29-day metric excludes pre-submission review time spent between the applicant and the third-party organization. Each third-party median uses every clearance with a Y flag in its address group. These records represented 162 of 9,667 non-U.S. clearances (1.7%) and 214 of 8,894 U.S. clearances (2.4%) [6](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-6). They also belong to the submission types already counted: Traditional (152 non-U.S., 199 U.S.), Special (7, 9) and Abbreviated (3, 6). FDA’s DXN classification record lists eligibility for third-party review, as checked in November 2026 [12](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-12).

All non-exempt 510(k) submissions must be prepared using FDA's electronic Submission Template And Resource (eSTAR) [21](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-21). FDA's eSTAR program documentation clarifies that eSTAR submissions are not anticipated to undergo the traditional 15-day Refuse to Accept (RTA) screening checklist [21](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-21). Instead, FDA conducts automated virus scanning and technical screening; if an eSTAR submission is incomplete, FDA may place it on technical screening hold for up to 180 days [21](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-21). For deeper analysis of submission track tradeoffs, see Pure Global's research on [510(k) pathway selection and review clocks](https://www.pureglobal.com/blog-posts/us-fda-510k-pathway-selection-3p510k-estar-review-clocks-2026) [FDA 510(k) Pathway Selection: Evidence, Review Clocks and Costs in 2026 (Pure Global Deep Research)](https://www.pureglobal.com/blog-posts/us-fda-510k-pathway-selection-3p510k-estar-review-clocks-2026).

Obtaining 510(k) clearance establishes a baseline that requires ongoing design-change control under 21 CFR 807.81(a)(3)(i) [17](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-17). On June 12, 2026, CDRH issued a Warning Letter to Nihon Kohden Digital Health Solutions, LLC (CMS 727803), citing the company after a facility inspection revealed that software modifications introducing a "Silence Alarms" function were implemented under an internal letter-to-file without submitting a new 510(k), alongside an intended-use change cited under 21 CFR 807.81(a)(3)(ii) [22](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-22). An internal rationale must withstand FDA scrutiny regarding whether the modification could significantly affect the safety or effectiveness of the device.

* * *

## FURLS Registration, U.S. Agent Representation, and Initial Importer Compliance

The launch and role tables track the foreign manufacturer, U.S. agent, initial importer and customs broker. The foreign exporter supplies its own registration details where required and may be the same establishment as the manufacturer. The manufacturer separately names an official correspondent for establishment records.

Top 12 Non-U.S. Jurisdictions by Country-Identified Establishments with Active Device ListingsIn FDA's public registration and listing extract (snapshot August 24, 2026), non-U.S. establishments account for 60.1% (15,370 of 25,566) of country-identified establishments with at least one active finished device listing, compared with 10,196 U.S. establishments (1.51 non-U.S. establishments for each U.S. establishment). U.S. Initial Importers register under 21 CFR 807.20(a)(5) without listing devices and are structurally absent from this listing-based extract.Establishments
|  | Establishments with Active Device Listings |
| --- | --- |
| China | 4,998 |
| Germany | 1,080 |
| South Korea | 886 |
| Canada | 656 |
| Taiwan | 620 |
| United Kingdom | 619 |
| Japan | 532 |
| Italy | 518 |
| France | 457 |
| Israel | 385 |
| India | 382 |
| Mexico | 351 |

Source: FDA Device Registration and Listing Database (snapshot August 24, 2026); Pure Global analysis, accessed August 2026

In FDA's public registration and listing database (snapshot August 24, 2026), 15,370 of 25,566 country-identified establishments with an active device listing (60.1%) are non-U.S. sites (1.51 per U.S. establishment). The non-U.S. sites account for 217,566 listing rows and the 10,196 U.S. sites account for 202,084 listing rows [23](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-23). China accounts for 4,998 registered establishments with active device listings (32.5% of foreign sites, 47,950 listing rows), followed by Germany (1,080 establishments, 25,680 listing rows), South Korea (886), Canada (656), Taiwan (620), the United Kingdom (619), Japan (532), Italy (518), France (457), Israel (385), India (382), and Mexico (351) [23](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-23).

### The Initial Importer Regulatory Structure: Separate Registration and Fee Without Device Listing

Analysis of the 419,651 active listing rows in openFDA's extract reveals that zero rows contain an Initial Importer establishment type [23](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-23). This reflects the regulatory design of the registration and listing system. Under 21 CFR 807.20(a)(5) and FDA's official matrix _Who Must Register, List and Pay the Fee_, an Initial Importer must register each establishment and pay the annual establishment registration fee, but it fulfills its listing obligation by submitting the name and address of the foreign manufacturer [2](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-2) [24](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-24). FDA's registration matrix marks device listing for initial importers as "NO," with the explicit instruction to identify foreign manufacturers under 807.20(a)(5) [24](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-24). Conversely, under 21 CFR 807.41, foreign establishments must submit the name, address, and contact information of each known importer, with the listed devices it receives, and each agent, broker or other person used to facilitate import, upon initial registration, annually, and at the time of any changes [8](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-8). Because public listing extracts report establishment-product pairs, initial importers do not appear in openFDA listing feeds.

Under 21 CFR 807.3(g), an Initial Importer is defined as any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes final delivery or sale to the ultimate consumer or user, but does not repackage or otherwise change the container, wrapper, or labeling of the device [25](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-25). FDA guidance clarifies that the initial importer must have a physical address in the United States staffed by individuals responsible for ensuring device compliance, and it exempts entities that do not take first possession of the imported goods [24](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-24). Under 21 CFR 830.3, a labeler causes a label to be applied, replaced or modified with the intent to distribute the device commercially without further label changes. Adding only a distributor’s name and contact information is outside the definition of a label modification for this purpose [26](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-26) [One Device, Three UDI Databases (2026): Build the US, EU and China Work Order (Pure Global Deep Research)](https://www.pureglobal.com/blog-posts/udi-us-eu-china-compliance-workorder-2026).

Foreign establishments manufacturing, preparing, propagating, compounding, or processing devices imported into the United States must register annually, list all finished devices, and designate exactly one U.S. Agent under 21 CFR 807.40 [27](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-27). The annual registration renewal period runs from October 1 through December 31 each year [28](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-28). FDA guidance specifies that foreign manufacturers must complete registration before exporting devices to the United States, and domestic initial importers must register before importing devices [28](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-28).

### Regulatory Role Matrix: U.S. Agent vs. Official Correspondent vs. Initial Importer vs. Customs Broker

| Attribute & Regulatory Scope | U.S. Agent (21 CFR 807.40) | Official Correspondent (21 CFR 807.25) | U.S. Initial Importer (21 CFR 807.3(g)) | Licensed Customs Broker / Importer of Record |
| --- | --- | --- | --- | --- |
| **Physical Location Requirement** | Must reside or maintain a place of business in the U.S. [27](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-27). The definition in 21 CFR 807.3(s) excludes mailboxes and answering machines or services [25](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-25) | Section 807.40 specifies a U.S. location for the U.S. Agent only. It allows the foreign establishment to designate that agent as official correspondent [27](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-27) | Must maintain a physical establishment in the U.S. taking first possession of imported devices [25](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-25) [24](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-24) | U.S. licensed customs broker / Importer of Record (transmitted as FD1 in ACE); can be importer or broker [1](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-1) |
| **FURLS Registration & Fee** | Acts as official correspondent for registration if the establishment designates it under 21 CFR 807.40(b) [27](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-27). The U.S. Agent role does not appear among the establishment types that register and pay in FDA’s matrix [24](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-24) | Provides the required registration and listing information to FDA electronically, subject to the electronic-filing waiver under 21 CFR 807.25(e) [29](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-29) | **Must register and pay the annual establishment registration fee** per U.S. establishment [5](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-5) [24](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-24) | Not required to register as an FDA medical device establishment solely to perform customs brokerage |
| **Device Listing Obligations** | Facilitates foreign owner filings; holds no independent listing ownership | Submits foreign establishment listings (LST), links premarket numbers, and identifies importers under 21 CFR 807.41 [8](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-8) | Identifies foreign manufacturers under 21 CFR 807.20(a)(5) [2](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-2) [24](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-24) | Transmits DEV, DFE, LST, and PM# in ACE PG23 messages without modifying FURLS |
| **FDA Inspection & Communication Role** | **Communication conduit:** under 21 CFR 807.40(b)(2), FDA documents provided to the agent are equivalent to providing them to the foreign establishment if FDA cannot contact the foreign establishment directly or expeditiously; assists in scheduling foreign inspections [27](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-27) | Receives FDA correspondence concerning registration and listing under 21 CFR 807.25(e) [29](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-29) | **Subject to direct on-site FDA facility inspection** for post-market importer responsibilities [30](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-30) | Responds to CBP and FDA port examination notices and cargo holds via PG21 contact [1](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-1) |
| **Statutory & Regulatory Vigilance Duties** | FDA guidance explicitly disclaims MDR reporting (Part 803) and 510(k) submission responsibilities as agent duties [31](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-31) | No inherent post-market reporting duties unless assigned by manufacturer contract | **Direct regulatory obligations:** 21 CFR 803.40 (MDR reporting), 21 CFR 806.10 (corrections/removals), 21 CFR 820.35(a) (complaint files under 820.1(a)) [32](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-32) [33](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-33) [34](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-34) [35](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-35) | No post-market vigilance or complaint handling obligations after customs release (unless acting as initial importer) |
| **Commercial Arrangement & Change Flexibility** | Report a change of U.S. Agent to FDA within 10 business days of the change under 21 CFR 807.40(b)(3) [27](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-27) | Controlled directly by manufacturer FURLS account holder | Changing commercial distributors requires updating PG19 DII entity records, updating FURLS under 807.41, and transitioning complaint files | Switching customs brokers requires updating FURLS broker records under 807.41 and reissuing master ACE filing instructions [8](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-8) |

In Pure Global's view, appointing a commercial distributor as U.S. Agent can function when the distributor has established regulatory capabilities and contractual terms ensure rapid communication. However, if commercial relations deteriorate, having a commercial partner control the primary FDA communication channel poses operational risks. A manufacturer that changes its U.S. Agent must report the change within 10 business days [27](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-27). In Pure Global’s view, appointing an independent regulatory specialist reduces dependence on a commercial partner. For comparative analysis of representative structures, see Pure Global's research on [in-country representatives and registration holders](https://www.pureglobal.com/blog-posts/in-country-representative-registration-holder-decision-2026) [In-Country Representatives and Registration Holders: 2026 Guide (Pure Global Deep Research)](https://www.pureglobal.com/blog-posts/in-country-representative-registration-holder-decision-2026).

### Enforcement Evidence: December 2025 Website Actions and May 2026 Dual Importer/Manufacturer Warning Letters

Two sets of letters between December 2025 and May 2026 show what FDA cited in these cases:

1.  December 16, 2025 E-Commerce Website Actions: On December 16, 2025, CDRH issued parallel Warning Letters targeting sellers of chest and breast binders promoted for medical indications without registration or listing under Section 510 of the FD&C Act, citing the devices as misbranded under Section 502(o) [36](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-36) [37](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-37). Foreign recipients included Trans-Missie B.V. (CMS 720852, Netherlands) and Flux Lab Pte. Ltd. d/b/a The Fluxion (CMS 720847, Singapore) [36](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-36) [37](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-37). In these letters, FDA cited claims found on the firms’ websites and agency records showing FY2026 registration and listing failures [36](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-36) [37](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-37). Flux Lab subsequently completed corrective actions and received a formal Close-Out Letter on March 27, 2026 (posted April 7, 2026) [38](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-38).
2.  May 20, 2026 Paired Warning Letters (3B Medical and BMC Medical): Following an FDA inspection from December 1 to 10, 2025 of 3B Medical, Inc. d.b.a. React Health, located in Dublin, Ohio, FDA issued paired Warning Letters on May 20, 2026—one to the Ohio facility (CMS 725108) and a companion letter directly to Beijing-based specification developer and 510(k) holder BMC Medical Co., Ltd. (CMS 725759) [30](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-30) [39](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-39). The 3B Medical inspection uncovered that 7 of 11 sampled complaint records were cancelled despite meeting the regulatory definition of a complaint, 3 of 11 records lacked documented follow-up, and corrective actions across third-party warehouses failed to prevent distribution of nonconforming units [30](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-30). Drawing on design records obtained at the Ohio facility (Design Change Evaluation Report nP3), FDA cited foreign manufacturer BMC Medical under 21 CFR 807.81(a)(3)(i) for implementing algorithm modifications (Flow Limitation, RERA, and Periodic Breathing), changing gas-pathway sound materials, and replacing a PCBA chip on its _Luna G3 / G3X APAP_ devices without submitting a new 510(k), alongside failing to report a field correction under 21 CFR 806.10 for firmware updates addressing unexpected device shutdowns [39](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-39).

These paired Warning Letters show that FDA used records reviewed at a U.S. importer's facility to establish regulatory noncompliance against foreign design authorities.

### Initial Importer Quality Agreement SLA Checklist

To prevent operational gaps across U.S. distribution networks, foreign manufacturers should bind U.S. initial importers under an enforceable Quality and Vigilance Agreement. Under 21 CFR 820.1(a), Part 820 applies to initial distributors of foreign entities, limited to those requirements applicable to the operations they perform [32](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-32). The following checklist details the regulatory basis, legal obligations, Pure Global's suggested contract terms, and operational failure modes:

| Regulatory Obligation & Citation | Importer Regulatory Duty | Suggested Contract Term (Pure Global) | Operational Failure Mode Addressed |
| --- | --- | --- | --- |
| **Complaint Handling & Forwarding** (21 CFR 820.35(a) / 820.1(a) / ISO 13485 Clause 8.2.2) [40](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-40) [32](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-32) [35](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-35) | Maintain complaint files under 21 CFR 820.35(a), capturing all mandatory fields and investigating complaints applicable to its operations [32](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-32) [35](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-35) | Importer forwards all customer feedback and complaints to manufacturer within 48 hours; preserves raw records through any administrative closure | Addresses improper closure of complaints meeting regulatory definitions, as cited in Warning Letter CMS 725108 (7 of 11 sampled complaints cancelled) [30](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-30) |
| **Importer MDR Reporting** (21 CFR 803.40) [33](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-33) | Submit reports of deaths and serious injuries to FDA and the manufacturer (803.40(a)), and reportable malfunctions to the manufacturer (803.40(b)), as soon as practicable and no later than 30 calendar days after the day the importer receives or otherwise becomes aware of the information [33](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-33) | Set five business days after awareness as the contractual ceiling for notice to the manufacturer. Act sooner where required. Coordinate the assessment without delaying required reporting | Addresses duplicate, conflicting, or omitted 30-calendar-day MDR submissions across distributed organizations |
| **Corrections & Removals** (21 CFR 806.10 & 807.81(a)(3)) [34](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-34) [17](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-17) | Report within 10 working days after initiating a correction or removal to reduce a risk to health or remedy a violation that may present a risk to health, subject to the applicable exceptions [34](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-34) | Importer prohibited from executing field modifications, rework, or software updates without written manufacturer authorization | Addresses unfiled field corrections and unapproved modifications, such as firmware updates cited in Warning Letter CMS 725759 [39](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-39) |
| **Quarantine & Distribution Control** (ISO 13485 Clause 8.3 / 21 CFR 820.1(a)) [18](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-18) [32](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-32) | Segregate nonconforming or returned devices to prevent unintended commercial distribution, applicable to warehousing operations [32](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-32) | Dedicated physical and electronic quarantine holds at third-party logistics warehouses; release requires written QA signoff | Addresses distribution of uncontained nonconforming units from third-party logistics facilities [30](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-30) |
| **UDI & Labeling Verification** (21 CFR 830.3 / 807.3(g)) [26](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-26) [25](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-25) | The initial importer definition in 21 CFR 807.3(g) covers an importer that does not repackage or otherwise change the container, wrapper or labeling of the device [25](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-25). A firm causing a label to be applied or modified may be the labeler under 21 CFR 830.3 and a relabeler for registration purposes, subject to the relevant definitions [26](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-26) | Incoming inspection verifies UDI barcode legibility and English package labeling; prohibits over-labeling | Pure Global suggests this check to catch damaged UDI carriers and unauthorized relabeling |
| **Device Tracking Compliance** (21 CFR Part 821) [41](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-41) | Maintain tracking records linking devices to consignees, **applicable only if FDA has issued a specific tracking order under 21 CFR 821.1** [41](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-41) | Importer maintains lot-traceable distribution logs capable of tracing units to end consignees within 24 hours (if tracking ordered) | Supports Part 821 compliance if FDA issues a tracking order |

* * *

## QMSR Readiness and Inspection Exposure Effective February 2, 2026

On February 2, 2026, FDA's Quality Management System Regulation (QMSR) final rule (89 FR 7496, published February 2, 2024) took effect, amending 21 CFR Part 820 by incorporating the international quality standard ISO 13485:2016 (and ISO 9000:2015 Clause 3 definitions) directly into U.S. federal regulation [40](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-40). CDRH simultaneously retired the legacy Quality System Inspection Technique (QSIT) in favor of Compliance Program 7382.850 [42](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-42). In its May 20, 2026 letter to BMC Medical, FDA stated that corrective actions taken after February 2, 2026 must meet QMSR requirements [39](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-39).

Three regulatory provisions govern foreign launch readiness under revised Part 820:

1.  Commercial Import Admissibility (21 CFR 820.1(a)(1) & 820.1(c)): Part 820 applies explicitly to finished devices manufactured outside the United States and offered for import [32](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-32). Under 21 CFR 820.1(c), an imported device that appears to be adulterated because it was not manufactured in compliance with QMSR is subject to refusal of admission to the United States under Section 801(a) of the Federal Food, Drug, and Cosmetic Act [32](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-32).
2.  Additional FDA Provisions Layered Over ISO 13485 (21 CFR 820.10(b) & 820.35): While ISO 13485 satisfies core quality system requirements, 21 CFR 820.10(b) mandates compliance with UDI labeling (Part 830) under Clause 7.5.8, Device Tracking (Part 821, if applicable) under Clause 7.5.9.1, Medical Device Reporting (Part 803) under Clause 8.2.3, and Reports of Corrections and Removals (Part 806) under Clauses 7.2.3, 8.2.3, and 8.3.3 [18](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-18). Furthermore, 21 CFR 820.35 establishes recordkeeping controls over complaints and servicing [35](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-35). For complaints reportable under Part 803, complaints the manufacturer determines must be investigated, and complaints investigated regardless, 21 CFR 820.35(a)(1)–(7) mandates that records include: (1) the name of the device; (2) the date the complaint was received; (3) any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s); (4) the name, address, and phone number of the complainant; (5) the nature and details of the complaint; (6) any correction or corrective action taken; and (7) any reply to the complainant [40](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-40) [35](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-35).
3.  Design Control Scope (21 CFR 820.10(c)): Under 21 CFR 820.10(c), manufacturers of Class I devices are exempt from ISO 13485 Clause 7.3 (Design and Development) unless the device is automated with computer software or listed in five designated regulations (868.6810, 878.4460, 880.6760, 892.5650, 892.5740) [18](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-18). Because Product A (SDV, 21 CFR 880.2910) and Product B (DXN, 21 CFR 870.1130) are both Class II devices, both remain subject to ISO 13485 Clause 7.3 design controls, requiring complete design and development files [18](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-18).

### Inspection Realities: Internal Audits and MDSAP Status Under QMSR FAQ

FDA's published QMSR Frequently Asked Questions page (content current November 5, 2026) clarifies two critical inspection realities for foreign manufacturers [42](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-42):

-   Internal Audits, Management Reviews, and Supplier Audit Reports Are Inspectable (FAQ Q8): Legacy 21 CFR 820.180(c) shielded internal quality audit reports, management reviews, and supplier audit reports from routine FDA inspection. FDA's FAQ Q8 explains that this exception was removed under QMSR, meaning FDA investigators reviewing foreign or domestic facilities can inspect internal audit reports, management review records, and supplier audit findings [42](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-42).
-   ISO 13485 Certificates and MDSAP Audit Reports (FAQ Q13 & MDSAP Program Page): FAQ Q13 clarifies that "A certificate of conformance to ISO 13485 will not exempt a manufacturer from an FDA inspection" and that FDA inspections under QMSR "will not follow the MDSAP audit plan or procedures" [42](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-42). However, FDA's separate Medical Device Single Audit Program (MDSAP) page (content current December 19, 2025) specifies that "The FDA may continue to accept MDSAP audit reports as a substitute for routine Agency inspections" [43](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-43). Holding an ISO 13485 certificate confers no exemption from inspection, whereas MDSAP participation allows FDA the discretion to substitute single-audit reports for routine surveillance inspections [42](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-42) [43](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-43).

### QMSR-Era and Foreign-Oversight Examples

Three letters show what FDA cited:

-   Linemaster Switch Corp. Warning Letter (CMS 730215, May 27, 2026): FDA inspected this U.S. accessory-device manufacturer from February 4 to March 6, 2026—initiating inspection two days after QMSR took effect [44](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-44). The Warning Letter cited five deficiencies anchored directly to ISO 13485:2016 clauses: Clause 8.3.4 (undocumented rework on foot controls); Clause 7.1 (risk management in product realization, citing missing Process FMEAs and failure to connect post-market complaints and adverse events back to risk files); Clause 8.5.2 (CAPA, citing a Supplier Corrective Action Request closed without identified root cause); Clause 6.4.1 (work environment temperature monitoring); and Clause 7.6 (validation of monitoring and measuring software lacking raw data and pass/fail criteria) [44](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-44).
-   Remote Regulatory Assessment (Unomedical Device S.A. de C.V., CMS 719428, January 8, 2026): Reviewing records submitted remotely from Reynosa, Mexico under Section 704(a)(4) of the FD&C Act, CDRH cited the foreign establishment for closing over 41,000 "Type 1" complaints between June 2023 and June 2025 without investigation solely because complainant lot numbers were missing, despite allegations involving device leaks and potential reportable events [45](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-45).
-   Foreign Port Detention Warning (Contec Medical Systems Co., Ltd., CMS 717941, October 2, 2025): Following an on-site inspection in Qinhuangdao, Hebei, China, FDA cited design validation, complaint investigation, and 21 CFR 806.10(c)(12) discrepancies regarding a paragraph omitted from the FDA-filed copy of a recall notification relative to the version sent to consignees [46](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-46). The letter warned that FDA is taking steps to refuse admission of the firm's devices at U.S. ports under Section 801(a) of the FD&C Act [46](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-46).

For clause-by-clause analysis of these early citations, see Pure Global's research on [QMSR Warning Letters and ISO 13485 records](https://www.pureglobal.com/blog-posts/qmsr-warning-letters-iso-13485-records-2026) [QMSR Warning Letters 2026: The ISO 13485 Records FDA Named (Pure Global Deep Research)](https://www.pureglobal.com/blog-posts/qmsr-warning-letters-iso-13485-records-2026).

### QMSR Migration Map: Legacy 21 CFR Part 820 vs. ISO 13485:2016 + QMSR Requirements

| Quality System Area | Legacy 21 CFR Part 820 Provision | Active QMSR Provision (ISO 13485:2016 + 21 CFR Part 820) | Recommended Foreign-Facility Action (Pure Global) |
| --- | --- | --- | --- |
| **Lifecycle Risk Management** | 21 CFR 820.30(g) (risk analysis within design validation) | ISO 13485 Clauses 7.1, 7.3, 8.2, 8.5 embedded across realization and remediation [44](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-44) | Establish living Process FMEAs connected to post-market complaint, adverse event, and recall trending |
| **Quality Audits & Management Reviews** | 21 CFR 820.180(c) (historical exception shielding audit reports) | ISO 13485 Clauses 5.6, 8.2.4; **QMSR FAQ Q8** confirms audit and review reports are inspectable [42](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-42) | Remove redaction assumptions from internal audits, supplier audit files, and management review minutes |
| **Complaint Handling & Documentation** | 21 CFR 820.198 (complaint files) | ISO 13485 Clause 8.2.2 + **21 CFR 820.35(a)(1)–(7)** (seven mandatory fields) + 820.10(b)(3) MDR tie-in [40](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-40) [35](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-35) | Ensure complaint SOPs require all seven mandatory fields established under 21 CFR 820.35(a) |
| **Field Corrections & Advisory Notices** | 21 CFR 820.100 / 820.198 | ISO 13485 Clauses 7.2.3, 8.2.3, 8.3.3 + **21 CFR 820.10(b)(4)** referencing Part 806 [18](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-18) [34](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-34) | Align advisory notice procedures to FDA's **10-working-day 21 CFR 806.10** reporting requirement |
| **UDI & Traceability Systems** | 21 CFR 820.60 / 820.65 (identification and traceability) | ISO 13485 Clauses 7.5.8, 7.5.9.1 + **21 CFR 820.10(b)(1)–(2)** referencing Parts 830 & 821 [18](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-18) [26](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-26) [41](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-41) | Embed GUDID-verified UDI carriers into medical device files and verify Part 821 tracking rules (if ordered) |
| **Work Environment & Software Validation** | 21 CFR 820.70(c) / 820.70(i) | ISO 13485 Clauses 6.4.1 & 7.6 (monitoring software validation) [44](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-44) | Log production environmental controls and preserve validation protocols, raw data, and pass/fail criteria |
| **Supplier Corrective Actions & Admissibility** | 21 CFR 820.50 / 820.100 + 820.1 | ISO 13485 Clauses 7.4 & 8.5.2 + **21 CFR 820.1(a)/(c)** import admissibility linkage [32](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-32) [44](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-44) | Require documented root-cause investigations on SCARs and maintain authenticated English records |

In Pure Global's view, conducting a structured two-day internal audit against these provisions helps foreign manufacturers identify and remediate QMSR gaps prior to commercial dispatch.

* * *

## CBP ACE Entry Architecture, Affirmations of Compliance, and Customs Tariffs

Even after FDA premarket and FURLS steps, cargo may be delayed when a customs broker transmits inaccurate Partner Government Agency (PGA) data into U.S. Customs and Border Protection's (CBP) Automated Commercial Environment (ACE). FDA screens device entries electronically. The data a filer transmits are set out in the _FDA Supplemental Guide for the Automated Commercial Environment/International Trade Data System_, version 2.6, and _FDA Affirmations of Compliance for the Automated Commercial Environment_ [1](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-1) [7](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-7).

### ACE Message Segment Architecture: PG01 Through PG23

FDA states that foreign establishments whose devices are imported must comply with applicable U.S. regulations before, during and after importation [47](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-47). Under Chapter 11 (Medical Devices) of Supplemental Guide v2.6, commercial device filings require distinct data elements across several message segments [1](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-1):

1.  PG01 Program & Intended Use Header: Commercial entries declare Government Agency **FDA**, Program Code **DEV**, Processing Code **NED** (Non-Radiation Emitting, applicable to VeloMed's SDV thermometer and DXN blood pressure monitor) or **RED** (Radiation Emitting), and Intended Use Code **081.001** (Standard Commercial Import of a Finished Medical Device) [1](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-1).
2.  PG02 FDA Product Code: Transmits qualifier **FDP** carrying the 7-character FDA product code (constructed across Industry Code, Class, Subclass, PIC, and Product Code, verified via FDA's Product Code Builder) [1](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-1).
3.  PG06 Product Origin: Transmits Source Type **39** (Country of Production for finished devices) or **30** (Country of Source for components under IUC 081.007), combined with the ISO 2-letter country code (**CN** for VeloMed). Code **294** may indicate that a country previously refused the line items [1](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-1).
4.  PG19, PG20, and PG21 Entities & Contact Information: Five mandatory entity roles apply to standard commercial finished devices (IUC 081.001): **MF** (Manufacturer, whose country code in PG20 must be outside the U.S.); **DEQ** (Shipper); **FD1** (FDA Importer / Importer of Record, accompanied by mandatory PG21 individual name, telephone, and email); **DII** (Device Initial Importer); and **DP** (Delivered-To Party) [1](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-1). Supplemental Guide v2.6 Table 11-11 specifies that the DII must have a physical address located within the United States, and even if an initial importer is exempt from registration, its U.S. name and address remain mandatory in PG19 [1](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-1). FDA prefers Entity Identification Code **47** (FEI number, 1 to 10 digits) over code **16** (DUNS number) [1](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-1).
5.  PG23 Affirmations of Compliance: Identifiers transmitted to verify registration and premarket status against FDA databases [1](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-1) [7](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-7).

CBP ACE Medical Device PGA Message Set Architecture (FDA Supplemental Guide v2.6)Successful CBP ACE entry transmission requires aligning PG01 intended use codes with mandatory PG19 foreign and domestic entities (including the physical U.S. address for the Device Initial Importer) and conditional PG23 affirmations, while omitting premarket numbers for exempt devices and strictly avoiding CDER drug registration codes.Reference table
| Import Scenario & Intended Use Code | PG01 Processing & PG06 Origin | PG19 / PG20 Mandatory Entities | PG23 Affirmations (M / C / O) | Filing Rules and Regulatory Boundaries |
| --- | --- | --- | --- | --- |
| Standard Commercial Finished Device — 510(k)-Exempt (IUC 081.001, e.g., Product A SDV) | DEV / NED; PG06 Source Type 39 (Country of Production) + country code; add 294 only if previously refused | MF (foreign manufacturer, non-US), DEQ, FD1 (+ PG21 contact), DII (U.S. address mandatory), DP; FEI (47) preferred over DUNS (16) | Mandatory: DEV (1-10N), DFE (1-10N), LST (e.g., D+6N); Conditional: LWC (if lead wires/cables per 21 CFR 898), IRC; Optional: DI | Omit PM# when 510(k)-exempt. Verify all three 21 CFR 880.2910(b) conditions: no telethermographic functions, no continuous temperature measurement functions, and completed analysis and testing validating specifications and performance. Apply 880.9. FDA’s FLL product-code definition covers thermometers indicated to measure continuously or at specified intervals. These thermometers require 510(k) clearance. |
| Standard Commercial Finished Device — 510(k)-Cleared (IUC 081.001, e.g., Product B DXN) | DEV / NED; PG06 Source Type 39 + Country Code | MF (non-US), DEQ, FD1 (+ PG21), DII (U.S. Initial Importer, physical U.S. address), DP | Mandatory: DEV, DFE, LST; Conditional/Required: PM# (K+6N), LWC; Optional: DI | PM# qualifier must match the exact premarket number linked to the active FURLS LST record; transmit LWC if patient cables or lead wires travel in carton |
| Radiation-Emitting Medical Device (IUC 081.001, e.g., Diagnostic X-Ray or Surgical Laser) | DEV / RED; PG06 Source Type 39 + Country Code | MF (non-US), DEQ, FD1 (+ PG21), DII, DP; trade/brand name mandatory in PG07 if Form 2877 applies | Mandatory: DEV, DFE, LST; Conditional: PM#, RB1 + ACC/ANC (or RA/RC/RD declaration codes) | Dual reporting rule: must transmit BOTH medical device affirmations and electronic Form FDA 2877 radiation control declarations on DEV/RED lines |
| Device Component for Further U.S. Manufacture (IUC 081.007) | DEV / NED; PG06 Source Type 30 (Country of Source for Component) + Country Code | MF, DEQ, FD1 (+ PG21), DII, DP | Mandatory: CPT (indicator only); Optional: LST, PM# | CPT is barred for articles that are already finished medical devices; article must require further manufacturing or incorporation into a finished device |
| Import for Export Only (IUC 970.000 / 970.001, Section 801(d)(3)) | DEV / NED (or RED); PG06 Source Type 39 (970.000) or 30 (970.001) | MF, DEQ, FD1 (+ PG21), DII, DP (export-incorporating initial owner/consignee) | Mandatory (970.000): DEV, DFE, IFE, LST; Mandatory (970.001): IFE, CPT, DDM, LST | IFE cannot be used for U.S. transshipment of devices or to store finished devices in U.S. warehouses awaiting foreign commercial distribution |
| Misapplied Drug Affirmation Code on Device Entry (Invalid Filing) | DEV / NED filed with Drug PG23 Code REG instead of DEV / DFE | Same entities, invalid identifier cross-reference | REG (Drug Registration Number — DUNS/FEI for CDER/CVM/CBER establishments only) | Table 11-17 of Supplemental Guide v2.6 lists valid device codes and omits REG; pre-entry review must verify DEV and DFE are transmitted for medical devices |

Affirmation codes DEV and DFE accept the Owner/Operator Number if the FDA establishment registration number has not yet been assigned, per FDA's October 14, 2026 Affirmations of Compliance for the Automated Commercial Environment.

Source: FDA Supplemental Guide for ACE/ITDS, Version 2.6 (March 10, 2026) and FDA Affirmations of Compliance for the Automated Commercial Environment (October 14, 2026)

### What the ACE Guide and AofC Manual Require of the Broker

Cross-checking Supplemental Guide v2.6 against the October 14, 2026 Affirmations of Compliance for the Automated Commercial Environment identifies three key filing rules where broker errors can lead to customs holds [1](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-1) [7](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-7):

-   Inapplicable Drug Code REG: In FDA’s Affirmations of Compliance for the Automated Commercial Environment, **REG** denotes a _Drug (Firm) Registration Number_ for CDER, CVM, or CBER establishments [7](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-7). Table 11-17 of the ACE Supplemental Guide lists valid affirmation codes for medical devices and omits **REG** [1](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-1). Device entries must transmit **DEV** (Foreign Manufacturer Registration Number) and **DFE** (Foreign Exporter Registration Number) [1](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-1) [7](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-7). FDA's Affirmations of Compliance for the Automated Commercial Environment specifies that affirmation codes DEV and DFE accept the Owner/Operator Number if the registration number has not yet been assigned [7](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-7).
-   Premarket Number (PM#) Alignment: For IUC 081.001, **DEV**, **DFE**, and **LST** (Listing Number, e.g., D-prefix followed by 6 digits) are mandatory [1](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-1) [7](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-7). **PM#** (Premarket Number: K-number for 510(k), P-number for PMA, DEN-number for De Novo) is conditional: it must be omitted for 510(k)-exempt devices such as VeloMed's SDV thermometer, but is strictly required for 510(k)-cleared devices like Product B (DXN) [1](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-1) [7](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-7). FDA's Affirmations of Compliance for the Automated Commercial Environment notes that "Premarket number should always be the number that is on the listing record" [7](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-7). If electrode lead wires or patient cables are included, affirmation **LWC** must be transmitted certifying compliance with 21 CFR Part 898 performance standards [7](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-7).
-   Prohibition on Warehousing Finished Devices Under IFE: Importers cannot use AofC code **IFE** (Import for Export under Section 801(d)(3) of the FD&C Act, IUC 970.000 or 970.001) to store finished devices in U.S. warehouses while awaiting foreign distribution. The FDA Affirmations of Compliance for the Automated Commercial Environment excludes transshipment and storage of finished devices in U.S. warehouses [7](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-7).

### Worked ACE Broker Master Payload: Product A vs. Product B

To prevent entry delays, manufacturers should provide customs brokers with a verified master data sheet prior to container dispatch [1](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-1) [7](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-7):

| ACE Segment & Data Element | Operational Purpose (Supplemental Guide v2.6) | Product A (_VeloTemp IR-200_, SDV Exempt) | Product B (_VeloPress BP-400_, DXN Cleared) |
| --- | --- | --- | --- |
| **PG01** Header Data | Agency, Program, Processing Code, Intended Use Code | **FDA** / **DEV** / **NED** / **081.001** | **FDA** / **DEV** / **NED** / **081.001** |
| **PG02** FDA Product Code | Item type P. FDP is the product-code qualifier. | Build and verify the seven-character clinical thermometer code in the FDA Product Code Builder before issuing the sheet. | Build and verify the seven-character noninvasive blood pressure monitor code in the FDA Product Code Builder before issuing the sheet. |
| **PG06** Origin Data | Source Type + ISO 2-letter Country Code | **39** (Country of Production) + **CN**; add **294** only if previously refused | **39** (Country of Production) + **CN**; add **294** only if previously refused |
| **PG19 / PG20** Mandatory Entities | Legal entities and physical addresses (FEI code **47** preferred) | **MF** (Suzhou plant, **CN**), **DEQ** (Suzhou, **CN**), **FD1** (IOR, **US**), **DII** (U.S. initial importer, **US** physical address mandatory), **DP** (consignee, **US**) | **MF** (Suzhou plant, **CN**), **DEQ** (Suzhou, **CN**), **FD1** (IOR, **US**), **DII** (U.S. initial importer, **US** physical address mandatory), **DP** (consignee, **US**) |
| **PG21** Contact Details | Individual contact for FDA port communications | **FD1** individual contact name, telephone, email; optional **PK** broker contact | **FD1** individual contact name, telephone, email; optional **PK** broker contact |
| **PG23** Mandatory AofCs | Establishment registration and listing numbers | **DEV** (Suzhou Reg # or Owner/Operator #), **DFE** (registration number of the exporting firm, or owner/operator number if FDA has not assigned the registration number. When the same firm manufactures and exports, confirm the filing value with the broker against FDA's guidance and its registration record), **LST** (FURLS Listing #) | **DEV** (Suzhou Reg # or Owner/Operator #), **DFE** (registration number of the exporting firm, or owner/operator number if FDA has not assigned the registration number. When the same firm manufactures and exports, confirm the filing value with the broker against FDA's guidance and its registration record), **LST** (FURLS Listing #) |
| **PG23** Conditional AofCs | Pathway-specific compliance affirmations | \*\***PM#** omitted \*\* (exempt under 21 CFR 880.2910(b) and 880.9); optional \*\* DI \*\* (UDI) | ****PM#** required \*\* (cleared K-number matching listing record); \*\* LWC \*\* if patient cables included; optional \*\* DI** |
| **PG23** Excluded Codes | Prohibited or inapplicable affirmation codes | Omit drug code **REG**; omit **IFE** (finished device staging barred) | Omit drug code **REG**; omit **IFE** (finished device staging barred) |

### Import Alert 89-08 and Port Detention Procedures

When FDA determines that a foreign manufacturer or product has shipped unapproved devices, it may place the entity on the Red List of Import Alert 89-08 (_Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)_) [14](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-14). Under published alert documentation, FDA Divisions may detain, without physical examination, shipments of products identified on the Red List under Section 801(a) of the FD&C Act [14](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-14).

If a shipment is detained under Import Alert 89-08, recovery follows procedures set forth in FDA's Regulatory Procedures Manual (RPM Chapter 9) and published alert documentation [14](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-14). Pure Global recommends the following sequential protocol:

1.  Consignment Triage (Form FDA 766): Under RPM 9-12, the importer or consignee may submit Form FDA 766 (Application for Authorization to Relabel or Perform Other Action to Bring Article into Compliance) to the local FDA Division compliance officer, which CDRH's Imports and Registration & Listing Team (IRLT) reviews for concurrence [14](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-14). Unapproved devices lacking required 510(k) clearance that cannot be brought into compliance must be exported or destroyed under CBP/FDA supervision.
2.  Commercial Claims Audit: Pure Global recommends reviewing all public English product listings, app interfaces, and user manuals to remove unapproved claims that exceed exemption limits (e.g., reverting continuous fever claims back to intermittent measurement).
3.  Underlying Compliance Remediation: Address the reason for detention. Where clearance is required, complete the 510(k) process [4](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-4). Resolve any separate quality or registration issues under the applicable requirements [40](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-40) [28](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-28).
4.  Petition for Removal (RPM 9-8): Submit a formal petition for DWPE removal to FDA's Division of Import Operations (DIO), which coordinates with CDRH IRLT, providing evidence of corrected operations and evidence that later shipments comply [14](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-14).
5.  Entry Pre-Audit: Pure Global recommends pre-auditing subsequent ACE message sets prior to export tender to ensure active FURLS alignment [1](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-1).

### U.S. Tariff Classification and Chapter 99 Checks

The candidate classifications and U.S. duty checks below reflect the tariff schedule and notices available on **November 13, 2026**. Confirm the exact product and origin with the broker before tender. Where the classification is uncertain, consider requesting a binding CBP ruling. Record the tariff classification and the FDA product code as separate fields [48](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-48) [49](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-49) [50](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-50).

Tariff checks for the two worked China-origin productsAs of November 13, 2026, the two products have the same Column 1 General rate and different conditions for relief from the original Section 301 action.Reference table
| Worked product | Candidate HTSUS | Column 1 General | Column 2 | Original China action | Current original-action exclusion | July 2026 action | Comparable CBP ruling |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Product A, clinical infrared thermometer | 9025.19.8010 | Free | 40% | 25%, 9903.88.02 | 9903.88.69 for 9025.19.8010 through Jan. 9, 2027 | 12.5%, 9903.05.31 for the worked use. Check 9903.05.89 for qualifying pharmaceutical use | N343624 (2024) |
| Product B, finished digital blood pressure monitor | 9018.19.9530 | Free | 35% | 25%, 9903.88.01 | 9903.88.69 through Jan. 9, 2027 if suitable for medical professionals | 12.5%, 9903.05.31 on the worked facts | H304293 (2020) |

The July Section 301 layer has independent exclusions. Confirm origin, actual specifications, intended users and date of entry before claiming relief.

Source: USITC HTS Chapters 90 and 99, CBP rulings N343624 and H304293, USTR 89 FR 46948 (Annex C), 91 FR 72610 and 91 FR 47318, CBP CSMS 69326983. Pure Global analysis.

-   **Product A, clinical infrared thermometer.** Candidate subheading 9025.19.80, statistical line 9025.19.8010. Column 1 General is Free and Column 2 is 40% [48](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-48). The comparable CBP ruling N343624 applied the original China List 2 rate of 25% under 9903.88.02 [49](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-49). The current exclusion names the entire 9025.19.8010 statistical line under U.S. note 20(vvv)(ii)(1) and heading 9903.88.69. It runs through January 9, 2027, at 11:59 p.m. Eastern Time [51](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-51) [52](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-52).
-   **Product B, finished digital upper-arm blood pressure monitor.** Candidate subheading 9018.19.95, statistical line 9018.19.9530. Column 1 General is Free and Column 2 is 35%. Use the separately described 9018.19.9560 line when classifying parts and accessories as applicable [48](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-48). In H304293, CBP applied the original China List 1 rate of 25% under 9903.88.01, subject to exclusions [50](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-50). Heading 9903.88.69 and note 20(vvv)(i)(35) cover blood pressure monitors suitable for use by medical professionals under 9018.19.9530, through the same January date. Verify the specifications and intended users before claiming it. If the worked device fails that description, use 25% for the original action [51](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-51) [52](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-52).

The separate July 2026 Section 301 action assigns China-origin goods a 12.5% default under 9903.05.31, subject to the exemptions in that action [53](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-53) [54](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-54). Product A's 9025.19.80 line appears in the pharmaceutical-use list in U.S. note 52(e). The corresponding 9903.05.89 exclusion also requires pharmaceutical use. An ordinary clinical thermometer qualifies for that exclusion only when the shipment satisfies the use condition. Product B's 9018.19.95 line is absent from the applicable general product lists reviewed. Model 12.5% for ordinary commercial entries of both products on the stated facts. The older China-list exclusion does not remove the separate July duty [53](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-53) [54](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-54).

For a $10,000 customs value and the stated ordinary clinical uses, the two Section 301 layers in this example produce $1,250 for Product A during the original exclusion window. For Product B, they produce $1,250 with the professional-use exclusion or $3,750 without it. If the exclusion expires as scheduled after January 9, 2027, apply both the 25% and 12.5% layers to the ordinary clinical examples, or $3,750 for either product at a $10,000 customs value. On the modeled timeline, Product B would enter after that date. The calculation excludes antidumping and countervailing duties, customs fees and Section 232 measures. The rates come from the older Section 301 action and exclusion [48](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-48) [51](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-51) [52](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-52) and the July action [53](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-53) [54](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-54). As checked on November 13, 2026, Commerce’s list included a Section 232 investigation of medical equipment, devices, consumables and PPE [55](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-55).

* * *

## FDA MDUFA User Fees, Pure Global Commercial Fees, and 3-Year Worked Budget

Commercial budgeting requires accounting for active FDA user fees, small business qualifications, commercial service fees, and ongoing foreign representative commitments across target markets.

### FDA MDUFA User Fees: FY2026 vs. Active FY2027 Rates

FDA operating fiscal years run from October 1 through September 30. Submissions and registrations made from October 1, 2026 fall under active **FY2027 MDUFA V user fee rates** (published at 91 FR 48134, effective October 1, 2026 through September 30, 2027) [5](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-5), which reflect increases over FY2026 rates (published at 2025-14412) [56](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-56):

| FDA MDUFA Fee Category | FY2026 Standard | FY2026 Small Business (<= $100M) | Active FY2027 Standard [5](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-5) | Active FY2027 Small Business [5](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-5) | Annual Rate Adjustment & Statutory Exclusions |
| --- | --- | --- | --- | --- | --- |
| **Annual Establishment Registration** | $11,423 [56](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-56) | **No reduction** ($11,423) | **$13,785** | **No reduction** ($13,785) | **+20.7%** YoY; applies to foreign manufacturers and separate initial importers [5](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-5) [24](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-24) |
| **510(k) Premarket Notification** | $26,067 | $6,517 | **$28,653** | **$7,163** | **+9.9%** YoY; $30M first-application waiver excludes 510(k) submissions [5](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-5) [19](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-19) |
| **513(g) Information Request** | $7,820 | $3,910 | **$8,596** | **$4,298** | **+9.9%** YoY; optional classification confirmation request [5](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-5) |
| **De Novo Classification Request** | $173,782 | $43,446 | **$191,020** | **$47,755** | **+9.9%** YoY [5](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-5) |
| **Premarket Approval (PMA)** | $579,272 | $144,818 | **$636,732** | **$159,183** | **+9.9%** YoY; $30M first-application waiver applies to PMA/PDP/BLA/PMR [5](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-5) [19](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-19) |

FDA’s Small Business Determination program uses gross receipts or sales for the most recent tax year, combined across the applicant and its domestic and foreign affiliates. The threshold for reduced eligible application or report fees is $100 million or less. For a foreign applicant, Form FDA 3602N calls for separate Section III National Taxing Authority certifications for the applicant and each foreign affiliate where the authority exists, plus the latest U.S. federal income tax return for each U.S. affiliate. FDA’s published review goal is 60 calendar days from receipt [19](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-19). Two waiver rules also matter:

1.  No SBD Discount on Establishment Registration: The standard annual establishment registration fee is $13,785 for small businesses [5](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-5) [19](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-19). An annual registration waiver is restricted to businesses with $1 million or less in combined receipts or sales, including domestic and foreign affiliates, that document financial hardship and evidence of a prior fiscal year’s registration fee payment and registration under their FDA owner/operator number [5](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-5) [19](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-19).
2.  First Premarket Application Waiver Excludes 510(k): The statutory waiver for a firm's first premarket submission (available where combined receipts or sales including domestic and foreign affiliates are $30 million or less and neither the applicant nor any affiliate previously submitted a qualifying first premarket application or report) is restricted to PMA, PDP, BLA, and PMR applications; 510(k) notifications are excluded [5](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-5) [19](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-19).

### Pure Global 2026 Commercial Service Fee Schedule

Commercial regulatory execution involves modular advisory and local representation retainers. Publicly verified fees and standard planning retainers include [Pure Global Regulatory Services Pricing (Pure Global)](https://www.pureglobal.com/services/pricing) [Pure Global U.S. FDA Agent for Medical Device Companies (Reviewed Oct 15, 2026) (Pure Global)](https://www.pureglobal.com/markets/united-states/us-fda-agent-for-medical-devices-companies) [Pure Global U.S. Medical Device Market Access (Pure Global)](https://www.pureglobal.com/markets/united-states):

-   U.S. Regulatory Pathway Assessment ($5,000 fixed project fee, Pure Global Master Price List, 2026): Verifies classification codes, evaluates 21 CFR 8xx.9 and 880.2910(b) exemption boundaries, identifies predicate devices, and establishes testing requirements.
-   U.S. FDA Agent Representative ($1,000/year, public rate): FURLS initial and annual establishment registration and listing support, annual user fee processing assistance, and U.S. Agent (21 CFR 807.40) and Official Correspondent communications [Pure Global Regulatory Services Pricing (Pure Global)](https://www.pureglobal.com/services/pricing) [Pure Global U.S. FDA Agent for Medical Device Companies (Reviewed Oct 15, 2026) (Pure Global)](https://www.pureglobal.com/markets/united-states/us-fda-agent-for-medical-devices-companies). Excludes 510(k) compilation, laboratory testing, MDR reporting, and commercial initial importer duties [Pure Global U.S. FDA Agent for Medical Device Companies (Reviewed Oct 15, 2026) (Pure Global)](https://www.pureglobal.com/markets/united-states/us-fda-agent-for-medical-devices-companies).
-   FDA Q-Submission Strategy & Meeting Support ($10,000–$15,000, Pure Global Master Price List, 2026): Pre-submission documentation preparation and FDA meeting management.
-   FDA 510(k) Compilation & Submission ($15,000–$20,000, Pure Global Master Price List, 2026): End-to-end eSTAR dossier preparation and submission management for Product B, excluding external testing and MDUFA user fees.
-   RAQA Advisory & Training ($250/hour, Pure Global Master Price List, 2026): QMSR gap assessments, complaint and MDR procedure remediation, and inspection readiness.
-   Multi-Market Representation (Standard 3-Year Contract Terms) [Pure Global Regulatory Services Pricing (Pure Global)](https://www.pureglobal.com/services/pricing): European Union Authorized Representative (EU AR) at $2,000/year for one device group [Pure Global Regulatory Services Pricing (Pure Global)](https://www.pureglobal.com/services/pricing) or $2,500/year for two groups (Pure Global Master Price List, 2026), paired with EU MDR Clinical Evaluation Plan/Report (CEP/CER) compilation ($18,000 compilation to $25,000 compilation and writing for Class IIa, Pure Global Master Price List, 2026); UK Responsible Person (UKRP) at $2,000/year for one registration [Pure Global Regulatory Services Pricing (Pure Global)](https://www.pureglobal.com/services/pricing) or $2,500/year for two registrations (Pure Global Master Price List, 2026); Australian Sponsor at $2,000/year for one registration [Pure Global Regulatory Services Pricing (Pure Global)](https://www.pureglobal.com/services/pricing) or $2,500/year for two registrations (Pure Global Master Price List, 2026); and Health Canada Medical Device Licence (MDL) compilation ($8,000–$10,000 for Class II, Pure Global Master Price List, 2026). Standard local representative agreements reflect a three-year contract commitment (one-year contracts incur a 50% Year 1 surcharge) [Pure Global Regulatory Services Pricing (Pure Global)](https://www.pureglobal.com/services/pricing). Testing laboratory fees, clinical trials, and government agency fees sit outside these commercial retainers.

### Worked 3-Year Regulatory Budget (FDA User Fees Plus Pure Global List Fees): Product A vs. Product B

_Note: The following budget models FDA user fees plus Pure Global list fees only. External laboratory testing (e.g., EMC, electrical safety, biocompatibility), Notified Body certification fees, non-U.S. national authority fees, and commercial distributor retainers sit outside this baseline. Three-year projections assume the active FY2027 FDA rate ($13,785/year) remains constant throughout the period; out-year rates for FY2028 and FY2029 are unpublished._ Non-U.S. classification assumes Class IIa under EU MDR and Class II under Canadian Medical Devices Regulations.

Worked 3-Year Regulatory Budget (FDA User Fees Plus Pure Global List Fees): Product A vs. Product BOver three years the modeled U.S. cost is $53,355 for exempt Product A and $99,008 to $119,008 for Product B at standard fees. The manufacturer’s FDA establishment registration ($41,355) is the largest line for both. Assumes active FY2027 FDA MDUFA V rates throughout the 3-year horizon. Totals include FDA user fees and Pure Global list fees only; external lab testing, Notified Body fees, and non-U.S. agency fees sit outside this model.Reference table
| Cost Line Item | Fee Schedule & Contractual Scope | Product A: SDV Exempt (USD) | Product B: DXN Standard (USD) | Product B: DXN SBD <=$100M (USD) | Concurrent A + B Portfolio (USD) |
| --- | --- | --- | --- | --- | --- |
| U.S. Regulatory Pathway Assessment (Year 1) | Pure Global fixed project fee ($5,000 per device); verifies product code, 21 CFR 8xx.9 boundaries, and predicate strategy | $5,000 | $5,000 | $5,000 | $10,000 |
| FDA Q-Submission Strategy & Meeting (Year 1) | Pure Global ($10,000–$15,000, optional when predicate or bench-test alignment needs pre-submission FDA feedback) | $0 | $0–$15,000 | $0–$15,000 | $0–$15,000 |
| FDA 510(k) Compilation & Submission (Year 1) | Pure Global eSTAR dossier compilation ($15,000–$20,000); excludes external EMC/safety/biocompatibility lab testing | $0 | $15,000–$20,000 | $15,000–$20,000 | $15,000–$20,000 |
| FDA 510(k) User Fee (Active FY2027 / FY2026 Ref.) | FDA MDUFA V: FY2027 $28,653 Std / $7,163 SBD (FY2026 ref.: $26,067 Std / $6,517 SBD; $30M first-app waiver excludes 510(k)) | $0 | $28,653 | $7,163 | $28,653 Std / $7,163 SBD |
| QMSR / RAQA Advisory & Training Support | Pure Global ($250/hr illustrative block: 16 hrs for SDV gap alignment; 24 hrs for DXN QMSR/design-control alignment; 40 hrs combined) | $4,000 | $6,000 | $6,000 | $10,000 |
| U.S. FDA Agent Representative (Years 1–3) | Pure Global ($1,000/yr x 3-yr standard term); includes FURLS reg/listing & annual fee support; excludes Initial Importer role | $3,000 | $3,000 | $3,000 | $3,000 |
| FDA Annual Establishment Registration (Years 1–3) | FDA FURLS: 1 foreign site x 3 yrs at FY2027 rate $13,785/yr ($41,355; FY2026 ref. $11,423/yr = $34,269). Separate Initial Importer pays separately. | $41,355 | $41,355 | $41,355 | $41,355 |
| U.S. 3-Year Subtotal (FDA Fees + Pure Global Fees) | Combined Pure Global U.S. services + FY2027 FDA user fees (excludes lab testing and importer registration) | $53,355 | $99,008–$119,008 | $77,518–$97,518 | $108,008–$128,008 Std / $86,518–$106,518 SBD |
| Separate Initial Importer Registration (Years 1–3) | Mandatory FDA fee paid directly by non-exempt U.S. Initial Importer under 21 CFR 807.20(a)(5) ($13,785/yr x 3 yrs) | $41,355 | $41,355 | $41,355 | $41,355 |
| Multi-Market Add-On: EU AR + MDR Class IIa CEP/CER (3 Yrs) | Pure Global EU AR ($2,000/yr x 3 = $6,000 for 1 group; $2,500/yr x 3 = $7,500 for 2 groups) + Class IIa CEP/CER ($18,000–$25,000 per device); Notified Body fees excluded | $24,000–$31,000 | $24,000–$31,000 | $24,000–$31,000 | $43,500–$57,500 |
| Multi-Market Add-On: UKRP + AU Sponsor (3 Yrs) | Pure Global UKRP ($2,000/yr x 3 = $6,000 for 1 group; $2,500/yr x 3 = $7,500 for 2 groups) + Australian Sponsor ($2,000/yr x 3 = $6,000; $2,500/yr x 3 = $7,500 for 2 regs); agency fees excluded | $12,000 | $12,000 | $12,000 | $15,000 |
| Multi-Market Add-On: Canada Class II MDL Compilation | Pure Global Canada Class II MDL dossier compilation ($8,000–$10,000 per device); Health Canada fees excluded | $8,000–$10,000 | $8,000–$10,000 | $8,000–$10,000 | $16,000–$20,000 |
| Total 3-Year Regulatory Budget (FDA Fees + Pure Global Fees) | U.S. (FY2027 baseline) + EU (Class IIa) + UK + Australia + Canada fees; excludes lab testing, Notified Bodies, & Initial Importer fee | $97,355–$106,355 | $143,008–$172,008 | $121,518–$150,518 | $182,508–$220,508 Std / $161,018–$199,018 SBD |

Pure Global Master Price List (2026) reflects standard 3-year representative terms (1-year contracts incur a 50% Year 1 surcharge). Concurrent A + B launch combines establishment registration ($41,355) and U.S. Agent retainers ($3,000), while accounting for two separate pathway assessments ($10,000 combined) and 40 combined QMSR advisory hours ($10,000). Multi-market concurrent expansion reflects two distinct Class IIa CEP/CER compilations ($36,000–$50,000) and two Canada Class II MDL compilations ($16,000–$20,000), plus representative retainers for two device groups ($22,500 total across EU, UK, and Australia). External laboratory testing, Notified Body fees, and Initial Importer retainers sit outside this baseline.

Source: Federal Register FY2027 MDUFA Notice (91 FR 48134); Pure Global Master Price List (2026); Pure Global analysis, accessed November 2026

Financial dynamics from VeloMed's worked 3-year model include:

1.  U.S. Standalone Baseline ($53,355 Exempt vs. $99,008–$119,008 Standard 510(k)): For Product A (SDV, 510(k)-exempt), FDA establishment registration fees alone ($41,355 over 3 years at the active FY2027 rate of $13,785/year) constitute 77.5% of the total 3-year U.S. regulatory spend ($53,355, including $5,000 pathway assessment, $4,000 QMSR advisory, and $3,000 U.S. Agent fees). For Product B (DXN, 510(k)-cleared), the 3-year U.S. regulatory total ranges from $99,008 to $119,008 at standard fees, dropping to $77,518 to $97,518 if approved for Small Business Determination ($7,163 vs. $28,653 510(k) fee). If a separate, non-exempt U.S. Initial Importer is used, that entity pays its own $13,785 annual establishment registration fee directly to FDA under 21 CFR 807.20(a)(5) ($41,355 over 3 years) [5](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-5) [24](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-24).
2.  Concurrent Portfolio Launch Savings: Launching Product A and Product B concurrently from the same foreign establishment combines establishment registration overhead ($41,355 over 3 years for the facility) and shares U.S. Agent retainers ($3,000 over 3 years). Accounting for two distinct pathway assessments ($5,000 each = $10,000), combined QMSR advisory support (16 hours for Product A plus 24 hours for Product B = 40 hours @ $250/hour = $10,000), Product B Q-submission ($0–$15,000) and 510(k) compilation ($15,000–$20,000), and the 510(k) user fee ($28,653 standard or $7,163 SBD), the combined 2-product U.S. subtotal is $108,008 to $128,008 at standard 510(k) rates, or $86,518 to $106,518 with Small Business Determination (covering FDA user fees plus Pure Global list fees only).
3.  FY2027 Rate Inflation Impact: Annual establishment registration increased by $2,362 per year over FY2026 ($13,785 vs. $11,423), adding ($13,785 - $11,423) × 3 = $7,086 over a three-year cycle on establishment fees alone [5](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-5) [56](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-56).
4.  Multi-Market Regulatory Expansion ($97,355–$172,008 Single-Product; $161,018–$220,508 Concurrent Portfolio): Adding local representation and dossier compilation across the EU (AR + Class IIa CEP/CER), UK (UKRP), Australia (Sponsor), and Canada (Class II MDL) adds $44,000 to $53,000 for a single product group. When scaling both Product A and Product B concurrently, representative retainers increase by $500/year per market (from $2,000 to $2,500/year across EU, UK, and Australia, or +$4,500 over 3 years, totaling $22,500). Furthermore, because Product A and Product B represent distinct device types, each requires separate technical compilations: two EU MDR Class IIa CEP/CER dossiers ($18,000–$25,000 each = $36,000–$50,000) and two Health Canada Class II MDL applications ($8,000–$10,000 each = $16,000–$20,000). This brings the concurrent multi-market add-on to $74,500–$92,500, yielding a combined 5-market regulatory baseline of $182,508 to $220,508 at standard 510(k) fees, or $161,018 to $199,018 with Small Business Determination (reflecting FDA user fees plus Pure Global list fees only).

* * *

## Pre-Shipment Operational Checklist and Frequently Asked Questions

### Pre-Shipment Verification Checklist

Prior to releasing commercial medical device cargo from a foreign manufacturing facility, regulatory and logistics leads should verify five operational checkpoints:

1.  Classification and exemption. For SDV, confirm that the device and its software lack telethermographic and continuous temperature measurement functions. Check the labeling and marketing for either claim or an indication to measure at specified intervals under FDA’s FLL definition. Review the completed validation. For DXN, verify that each change since clearance was assessed under 21 CFR 807.81(a)(3) and FDA clearance was obtained before commercial distribution where a new 510(k) was required [3](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-3) [10](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-10) [12](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-12) [17](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-17).
2.  QMSR Quality and Design Records Verification: Confirm that Class II devices (both SDV and DXN) maintain the applicable design, risk, measurement and complaint records described in the QMSR section.
3.  Contractual Entity Separation (Pure Global Recommended Practice): Where commercial distributors serve as U.S. Agent, confirm established regulatory capabilities; otherwise maintain an independent U.S. Agent under 21 CFR 807.40. Pure Global recommends executing an Initial Importer Quality and Vigilance Agreement establishing complaint forwarding, MDR reporting (21 CFR 803.40), and correction/removal notification (21 CFR 806.10) protocols prior to commercial dispatch.
4.  FURLS Status: Confirm that establishment registrations and the device listing are active. Check the premarket number where applicable and identify each known importer with the devices it receives and each facilitating agent or broker under 21 CFR 807.41 [8](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-8).
5.  Broker Instruction Sheet (Pure Global Recommended Practice): Send the worked payload table for the applicable product and check it against the establishment and device records in FURLS.

### Frequently Asked Questions

**Can finished medical devices be warehoused in the U.S. prior to 510(k) clearance using AofC code IFE (IUC 970.000)?** No. Under FDA's October 14, 2026 Affirmations of Compliance for the Automated Commercial Environment, IFE applies strictly to articles imported for further manufacturing or incorporation into products for export under Section 801(d)(3) of the FD&C Act. FDA excludes transshipment and storage of finished devices in U.S. warehouses from this affirmation [7](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-7). Staging uncleared finished devices in U.S. distribution facilities subjects the goods to refusal of admission under Section 801(a) of the FD&C Act.

**Must a separate U.S. Initial Importer register and pay the annual fee in addition to the foreign manufacturer's fee?** Yes. Under 21 CFR 807.3(g) and FDA's registration matrix, any entity taking first possession of imported devices to further marketing must register its establishment and pay the annual establishment registration fee [5](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-5) [25](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-25) [24](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-24). The initial importer omits device product listings under 21 CFR 807.20(a)(5) but must be registered prior to importing products [2](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-2) [24](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-24) [28](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-28).

**What operational steps occur if a manufacturer replaces its U.S. commercial distributor mid-year?** While the foreign manufacturer's finished device product listings remain active, 21 CFR 807.41 requires the foreign establishment to update its electronic registration in FURLS at the time of any change to identify the new U.S. importer and any facilitating brokers [8](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-8). Each subsequent entry must name the new initial importer and its U.S. address in PG19. Transmit its FEI where available [1](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-1). Under FDA guidance, the new initial importer must complete FURLS establishment registration before importing products [28](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-28). Additionally, Pure Global recommends executing an Importer Quality and Vigilance Agreement with the new distributor governing 21 CFR 803.40 MDR reporting and 820.35(a) complaint handling before commercial shipments transfer custody.

**Can a customs broker verify ACE entry message syntax prior to cargo arrival?** Ask the broker to check message syntax before filing. FDA makes the admissibility decision on the transmitted entry [57](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-57). Pure Global recommends providing the approved instruction sheet and FURLS confirmations ten business days before freight tender.

* * *

## Methodology, Data Sources, and Scope Limitations

Quantitative analysis in this workpaper is based on primary federal databases and official documents:

-   FDA CDRH Product Classification Database (snapshot August 24, 2026): Analyzed 7,084 total product codes (6,564 classified under Class I, II, or III; 520 unclassified or specialized codes) cross-referencing **device\_class** against **submission\_type\_id** [12](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-12). Exemption shares reflect baseline regulatory classification before applying product-specific conditions or 21 CFR 8xx.9 limitations [12](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-12).
-   FDA Device Registration and Listing Database (snapshot August 24, 2026): Analyzed 419,651 active listing rows spanning 25,566 country-identified establishments and 21,903 distinct owner/operators (excluding 1 country-missing establishment) [23](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-23). Establishments were deduplicated by registration number, falling back on FEI or facility name/city/country for unassigned registration records [23](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-23). Multi-role establishments were disaggregated across delimited strings. U.S. Initial Importers are omitted from listing extracts by regulatory design under 21 CFR 807.20(a)(5) [2](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-2) [23](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-23).
-   FDA CDRH 510(k) Premarket Decisions Database (decisions through October 30, 2026): The extract contains 176,625 historical decision records [6](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-6). For the annual series and pathway cohorts we retained 510(k) substantial-equivalence decisions. We excluded the 201 De Novo classification grants dated 2021 through October 30, 2026 (DENG, submission types Direct and Post-NSE), and the 149 such grants from 2016–2020 in the annual series. Multi-year pathway analysis covers 18,561 clearances from 2021 through October 30, 2026 with country-identified applicant data (9,667 non-U.S. clearances and 8,894 U.S. clearances) [6](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-6). Each decision contributes to one submission type and separately to a third-party-flag group. Reported medians use every record in the relevant group, all with receipt-to-decision intervals from 0 through 3,650 days. Shares use the full address-group totals. The openFDA third-party cross-tab over the same decision dates reconciled both flag totals. Elapsed time measures total calendar days from FDA receipt (**date\_received**) to clearance (**decision\_date**), reflecting agency review and applicant hold time combined [6](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-6).
-   Recalls, Enforcement, and Warning Letters: Evaluated CDRH Recall Enterprise database (August 24, 2026 snapshot; 58,785 product-level recall records through mid-2026, analyzing root causes and event groupings, noting that 953 records cite "No Marketing Application" as root cause and 291 records dated 2024 by recall initiation date derived from 12 distinct events) [15](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-15). Warning Letter analysis evaluates ten specific primary compliance documents issued between October 2025 and June 2026 (CMS 717941, 719428, 720847, 720852, 725108, 725759, 725861, 727803, 730215, and the Flux Lab close-out notice) [30](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-30) [39](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-39) [13](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-13) [22](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-22) [36](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-36) [37](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-37) [38](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-38) [44](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-44) [45](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-45) [46](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-46). These records reflect observed regulatory actions and do not measure overall industry noncompliance rates.
-   Harmonized Tariff Schedule: The worked classifications use the November 2026 USITC schedule and comparable CBP rulings. The original Section 301 exclusion and July 2026 action were verified separately against U.S. notes 20 and 52, the USTR notices, and CBP implementation guidance [48](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-48) [49](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-49) [50](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-50) [51](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-51) [52](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-52) [53](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-53) [54](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-54).

The FDA’s Dual 510(k) and CLIA Waiver by Application guidance describes a combined package for in vitro diagnostic tests [58](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-58). The FDA’s K254262 decision record is an example with the Dual Track label [59](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#ref-59).

* * *

## Strategic Takeaways and Launch Coordination

Commercial success in the U.S. medical device market requires synchronizing regulatory classification, quality systems, establishment registration, and customs filings into a unified operational sequence:

1.  Confirm Exemption by Product Code and Intended Use: Validate 510(k) exemption boundaries against product-specific conditions (such as 21 CFR 880.2910(b) for infrared thermometers) and general limitations under 21 CFR 8xx.9. Marketing claims, companion software, or diagnostic indications can void an exemption and expose consignments to port detention.
2.  Separate U.S. Agent and Initial Importer Functions (Pure Global Recommended Practice): While a qualified commercial distributor can serve as U.S. Agent, Pure Global recommends maintaining an independent U.S. Agent for regulatory correspondence under 21 CFR 807.40 to avoid commercial conflicts of interest. Bind commercial initial importers under structured Quality and Vigilance Agreements governing 21 CFR 803.40 MDR reporting and 820.35(a) complaint handling. Separately, 21 CFR 807.41 requires the foreign establishment to keep its importer information current in the registration and listing system.
3.  Prepare for Inspectable QMSR Records: Under QMSR enforcement effective February 2, 2026, internal audits, management reviews, and supplier audits are inspectable by FDA investigators under FAQ Q8. Class II finished devices—whether 510(k)-exempt or cleared—must maintain complete ISO 13485 Clause 7.3 design and development files.
4.  Enforce Pre-Departure Broker Data Sheet Controls (Pure Global Recommended Practice): Supply customs brokers with the locked master data payload table prior to cargo dispatch to prevent data mismatches in ACE.

Foreign manufacturers preparing U.S. launches can engage Pure Global for U.S. FDA Agent representation ($1,000/year) [Pure Global Regulatory Services Pricing (Pure Global)](https://www.pureglobal.com/services/pricing) [Pure Global U.S. FDA Agent for Medical Device Companies (Reviewed Oct 15, 2026) (Pure Global)](https://www.pureglobal.com/markets/united-states/us-fda-agent-for-medical-devices-companies), Regulatory Pathway Assessments ($5,000, Pure Global Master Price List, 2026), eSTAR 510(k) compilation ($15,000–$20,000, Pure Global Master Price List, 2026), and QMSR advisory services ($250/hour, Pure Global Master Price List, 2026). All premarket applications remain subject to statutory FDA review without guaranteed clearance outcomes or timelines.

* * *

## References

1.  [FDA Supplemental Guide for the Automated Commercial Environment/International Trade Data System, Version 2.6 (March 10, 2026) (U.S. CBP & FDA)](https://www.cbp.gov/sites/default/files/2026-03/fdasupplementalguideversion2.6_508.pdf) cbp.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-1-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-1-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-1-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-1-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-1-5) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-1-6) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-1-7) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-1-8) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-1-9) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-1-10) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-1-11) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-1-12) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-1-13) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-1-14) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-1-15) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-1-16) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-1-17) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-1-18) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-1-19) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-1-20) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-1-21)
2.  [21 CFR § 807.20 — Who Must Register and Submit a Device List (Cornell LII (eCFR mirror))](https://www.law.cornell.edu/cfr/text/21/807.20) law.cornell.edu [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-2-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-2-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-2-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-2-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-2-5)
3.  [Medical Devices; Exemptions From Premarket Notification: Class II Devices; Clinical Electronic Thermometers (90 FR 25889, June 18, 2025) (Federal Register (FDA))](https://www.federalregister.gov/documents/2025/06/18/2025-11207/medical-devices-exemptions-from-premarket-notification-class-ii-devices-clinical-electronic) federalregister.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-3-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-3-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-3-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-3-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-3-5) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-3-6) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-3-7) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-3-8) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-3-9) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-3-10)
4.  [Premarket Notification 510(k) (FDA CDRH)](https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k) fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-4-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-4-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-4-3)
5.  [Medical Device User Fee Rates for Fiscal Year 2027 (91 FR 48134, effective Oct 1, 2026) (Federal Register (FDA))](https://www.federalregister.gov/documents/2026/07/30/2026-15335/medical-device-user-fee-rates-for-fiscal-year-2027) federalregister.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-5-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-5-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-5-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-5-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-5-5) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-5-6) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-5-7) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-5-8) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-5-9) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-5-10) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-5-11) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-5-12) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-5-13) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-5-14) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-5-15) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-5-16) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-5-17)
6.  [FDA CDRH 510(k) Premarket Notification Decisions (decisions through Oct 30, 2026) (FDA CDRH)](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm) accessdata.fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-6-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-6-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-6-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-6-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-6-5) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-6-6) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-6-7) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-6-8) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-6-9) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-6-10) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-6-11) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-6-12) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-6-13) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-6-14) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-6-15) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-6-16)
7.  [FDA Affirmations of Compliance for ACE (Oct 14, 2026) (FDA ORA/OII)](https://www.fda.gov/media/195908/download) fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-7-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-7-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-7-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-7-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-7-5) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-7-6) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-7-7) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-7-8) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-7-9) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-7-10) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-7-11) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-7-12) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-7-13) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-7-14)
8.  [21 CFR § 807.41 — Identification of Importers and Persons Who Import or Offer for Import (Cornell LII (eCFR mirror))](https://www.law.cornell.edu/cfr/text/21/807.41) law.cornell.edu [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-8-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-8-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-8-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-8-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-8-5) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-8-6)
9.  [21 CFR § 880.2910 — Clinical Electronic Thermometer (Cornell LII (eCFR mirror))](https://www.law.cornell.edu/cfr/text/21/880.2910) law.cornell.edu [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-9-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-9-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-9-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-9-4)
10.  [21 CFR § 880.9 — Limitations of Exemptions from Section 510(k) (Cornell LII (eCFR mirror))](https://www.law.cornell.edu/cfr/text/21/880.9) law.cornell.edu [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-10-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-10-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-10-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-10-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-10-5) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-10-6) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-10-7) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-10-8)
11.  [21 CFR § 870.1130 — Noninvasive Blood Pressure Measurement System (Cornell LII (eCFR mirror))](https://www.law.cornell.edu/cfr/text/21/870.1130) law.cornell.edu [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-11-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-11-2)
12.  [CDRH Product Classification Database (snapshot August 24, 2026) (FDA CDRH)](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm) accessdata.fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-12-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-12-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-12-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-12-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-12-5) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-12-6) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-12-7) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-12-8) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-12-9) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-12-10) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-12-11) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-12-12) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-12-13) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-12-14) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-12-15)
13.  [Warning Letter: BlephEx, LLC (CMS #725861, June 3, 2026) (FDA CDRH)](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/blephex-llc-725861-06032026) fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-13-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-13-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-13-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-13-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-13-5) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-13-6)
14.  [Import Alert 89-08: Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k) (FDA Import Alerts)](https://www.accessdata.fda.gov/cms_ia/importalert_244.html) accessdata.fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-14-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-14-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-14-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-14-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-14-5) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-14-6) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-14-7)
15.  [FDA CDRH Recalls Database (August 24, 2026 snapshot) (FDA CDRH)](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm) accessdata.fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-15-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-15-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-15-3)
16.  [FDA — How to Prepare a Special 510(k)](https://www.fda.gov/medical-devices/premarket-notification-510k/how-prepare-special-510k) fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-16-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-16-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-16-3)
17.  [21 CFR § 807.81 — When a Premarket Notification Submission Is Required (Cornell LII (eCFR mirror))](https://www.law.cornell.edu/cfr/text/21/807.81) law.cornell.edu [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-17-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-17-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-17-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-17-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-17-5)
18.  [21 CFR § 820.10 — Requirements for a Quality Management System (QMSR) (Cornell LII (eCFR mirror))](https://www.law.cornell.edu/cfr/text/21/820.10) law.cornell.edu [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-18-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-18-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-18-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-18-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-18-5) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-18-6) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-18-7) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-18-8)
19.  [Reduced Medical Device User Fees: Small Business Determination (SBD) Program (FDA CDRH)](https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/reduced-or-waived-medical-device-user-fees-small-business-determination-sbd-program) fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-19-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-19-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-19-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-19-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-19-5) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-19-6) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-19-7)
20.  [510(k) Third Party Review Program (FDA CDRH)](https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/510k-third-party-review-program) fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-20-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-20-2)
21.  [eSTAR Program (FDA CDRH)](https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program) fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-21-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-21-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-21-3)
22.  [Warning Letter: Nihon Kohden Digital Health Solutions, LLC (CMS #727803, June 12, 2026) (FDA CDRH)](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nihon-kohden-digital-health-solutions-llc-727803-06122026) fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-22-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-22-2)
23.  [FDA Device Registration and Listing Database (snapshot August 24, 2026) (FDA CDRH)](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm) accessdata.fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-23-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-23-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-23-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-23-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-23-5) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-23-6)
24.  [Who Must Register, List and Pay the Fee (FDA CDRH)](https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee) fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-24-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-24-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-24-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-24-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-24-5) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-24-6) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-24-7) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-24-8) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-24-9) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-24-10) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-24-11)
25.  [21 CFR § 807.3 — Definitions (Initial Importer) (Cornell LII (eCFR mirror))](https://www.law.cornell.edu/cfr/text/21/807.3) law.cornell.edu [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-25-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-25-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-25-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-25-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-25-5) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-25-6)
26.  [21 CFR § 830.3 — Unique Device Identification System Definitions (Cornell LII (eCFR mirror))](https://www.law.cornell.edu/cfr/text/21/830.3) law.cornell.edu [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-26-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-26-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-26-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-26-4)
27.  [21 CFR § 807.40 — Establishment Registration and Device Listing for Foreign Establishments (Cornell LII (eCFR mirror))](https://www.law.cornell.edu/cfr/text/21/807.40) law.cornell.edu [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-27-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-27-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-27-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-27-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-27-5) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-27-6) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-27-7)
28.  [When to Register and List (FDA CDRH)](https://www.fda.gov/medical-devices/device-registration-and-listing/when-register-and-list) fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-28-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-28-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-28-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-28-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-28-5)
29.  [21 CFR § 807.25 — Information required for device establishment registration and device listing (Cornell LII (eCFR mirror))](https://www.law.cornell.edu/cfr/text/21/807.25) law.cornell.edu [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-29-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-29-2)
30.  [Warning Letter: 3B Medical, Inc. d.b.a. React Health, Inc. (CMS #725108, May 20, 2026) (FDA CDRH)](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/3b-medical-inc-dba-reach-health-inc-725108-05202026) fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-30-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-30-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-30-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-30-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-30-5) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-30-6)
31.  [U.S. Agents for Foreign Medical Device Establishments (FDA CDRH)](https://www.fda.gov/medical-devices/device-registration-and-listing/us-agents) fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-31-1)
32.  [21 CFR § 820.1 — Scope (QMSR) (Cornell LII (eCFR mirror))](https://www.law.cornell.edu/cfr/text/21/820.1) law.cornell.edu [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-32-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-32-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-32-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-32-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-32-5) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-32-6) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-32-7) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-32-8) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-32-9)
33.  [21 CFR § 803.40 — If I am an importer, what reporting requirements apply to me? (Cornell LII (eCFR mirror))](https://www.law.cornell.edu/cfr/text/21/803.40) law.cornell.edu [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-33-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-33-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-33-3)
34.  [21 CFR § 806.10 — Reports of Corrections and Removals (Cornell LII (eCFR mirror))](https://www.law.cornell.edu/cfr/text/21/806.10) law.cornell.edu [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-34-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-34-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-34-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-34-4)
35.  [21 CFR § 820.35 — Control of Records (QMSR) (Cornell LII (eCFR mirror))](https://www.law.cornell.edu/cfr/text/21/820.35) law.cornell.edu [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-35-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-35-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-35-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-35-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-35-5) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-35-6)
36.  [Warning Letter: Trans-Missie B.V. (CMS #720852, Dec 16, 2025) (FDA CDRH)](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/trans-missie-bv-720852-12162025) fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-36-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-36-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-36-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-36-4)
37.  [Warning Letter: Flux Lab Pte. Ltd. (CMS #720847, Dec 16, 2025) (FDA CDRH)](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/flux-lab-pte-ltd-dba-fluxion-720847-12162025) fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-37-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-37-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-37-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-37-4)
38.  [Close-Out Letter: Flux Lab Pte. Ltd. (CMS #720847, Mar 27, 2026; posted Apr 7, 2026) (FDA CDRH)](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/flux-lab-pte-ltd-dba-fluxion-720847-03272026) fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-38-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-38-2)
39.  [Warning Letter: BMC Medical Co., Ltd. (CMS #725759, May 20, 2026) (FDA CDRH)](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bmc-medical-co-ltd-725759-05202026) fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-39-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-39-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-39-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-39-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-39-5)
40.  [Medical Devices; Quality System Regulation Amendments Final Rule (89 FR 7496, Feb 2, 2024; eff. Feb 2, 2026) (Federal Register (FDA))](https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments) federalregister.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-40-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-40-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-40-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-40-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-40-5)
41.  [21 CFR § 821.1 — Medical Device Tracking Requirements (Cornell LII (eCFR mirror))](https://www.law.cornell.edu/cfr/text/21/821.1) law.cornell.edu [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-41-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-41-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-41-3)
42.  [QMSR Frequently Asked Questions (Updated Nov 5, 2026) (FDA CDRH)](https://www.fda.gov/medical-devices/quality-management-system-regulation-qmsr/quality-management-system-regulation-frequently-asked-questions) fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-42-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-42-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-42-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-42-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-42-5) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-42-6)
43.  [Medical Device Single Audit Program (MDSAP) (FDA CDRH)](https://www.fda.gov/medical-devices/cdrh-international-affairs/medical-device-single-audit-program-mdsap) fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-43-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-43-2)
44.  [Warning Letter: Linemaster Switch Corp. (CMS #730215, May 27, 2026) (FDA CDRH)](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/linemaster-switch-corporation-730215-05272026) fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-44-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-44-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-44-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-44-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-44-5) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-44-6)
45.  [Warning Letter: Unomedical Device S.A. de C.V. (CMS #719428, Jan 8, 2026) (FDA CDRH)](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/unomedical-device-sa-de-cv-719428-01082026) fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-45-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-45-2)
46.  [Warning Letter: Contec Medical Systems Co., Ltd. (CMS #717941, Oct 2, 2025) (FDA CDRH)](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/contec-medical-systems-co-ltd-717941-10022025) fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-46-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-46-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-46-3)
47.  [Importing and Exporting Medical Devices (FDA CDRH)](https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/importing-and-exporting-medical-devices) fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-47-1)
48.  [USITC Harmonized Tariff Schedule of the United States, 2026 Revision 23 (November 10, 2026)](https://www.usitc.gov/2026_hts_revision_23) usitc.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-48-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-48-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-48-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-48-4) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-48-5)
49.  [CBP Ruling NY N343624 (Nov 5, 2024) — Classification of Infrared Thermometer (U.S. CBP)](https://rulings.cbp.gov/ruling/N343624) rulings.cbp.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-49-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-49-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-49-3)
50.  [CBP Ruling HQ H304293 (Nov 3, 2020) — Classification of Digital Blood Pressure Monitors (U.S. CBP)](https://rulings.cbp.gov/ruling/H304293) rulings.cbp.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-50-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-50-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-50-3)
51.  [USTR — Notice of Product Exclusion Extensions, 91 FR 72610 (November 10, 2026)](https://www.govinfo.gov/content/pkg/FR-2026-11-10/pdf/2026-22925.pdf) govinfo.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-51-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-51-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-51-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-51-4)
52.  [USTR — Notice of Extension of Certain Exclusions, 89 FR 46948, Annex C (May 30, 2024)](https://www.govinfo.gov/content/pkg/FR-2024-05-30/pdf/2024-11904.pdf) govinfo.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-52-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-52-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-52-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-52-4)
53.  [USTR — Notice of Actions in Section 301 Investigations of Acts, Policies, and Practices of Various Economies Related to the Failure of Each Economy To Impose and Effectively Enforce a Prohibition on the Importation of Goods Produced With Forced Labor, 91 FR 47318, Annex I and Annex II (July 28, 2026)](https://www.govinfo.gov/content/pkg/FR-2026-07-28/pdf/2026-15181.pdf) govinfo.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-53-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-53-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-53-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-53-4)
54.  [CBP — CSMS #69326983, Section 301 Forced Labor Import Duties](https://content.govdelivery.com/accounts/USDHSCBP/bulletins/421d887) content.govdelivery.com [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-54-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-54-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-54-3) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-54-4)
55.  [Bureau of Industry and Security — Section 232 Investigations. Medical equipment investigation initiated September 2, 2025.](https://www.bis.gov/about-bis/bis-leadership-and-offices/SIES/section-232-investigations) bis.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-55-1)
56.  [Medical Device User Fee Rates for Fiscal Year 2026 (2025-14412) (Federal Register (FDA))](https://www.federalregister.gov/documents/2025/07/30/2025-14412/medical-device-user-fee-rates-for-fiscal-year-2026) federalregister.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-56-1) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-56-2) [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-56-3)
57.  [FDA — Importing Medical Devices and Radiation-Emitting Electronic Products into the U.S..](https://www.fda.gov/medical-devices/importing-and-exporting-medical-devices/importing-medical-devices-and-radiation-emitting-electronic-products-us) fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-57-1)
58.  [FDA — Recommendations for Dual 510(k) and CLIA Waiver by Application Studies.](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-dual-510k-and-clia-waiver-application-studies) fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-58-1)
59.  [FDA — 510(k) Premarket Notification K254262.](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254262) accessdata.fda.gov [↩](https://www.pureglobal.com/blog-posts/us-fda-foreign-manufacturer-launch-sequence-ace-import-workpaper-2026#cite-59-1)

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