FDA Extends 510(k) Exemptions for 14 Toxicology Test Types

On 6 October 2026, the United States Food and Drug Administration (FDA) published and made immediately effective a final amendment and final order (Docket FDA-2026-N-4268; 91 FR 63478, FR Doc. 2026-20448; Federal Register HTML) expanding premarket notification (510(k)) exemptions across 14 Class II clinical toxicology test system regulations in 21 CFR Part 862, Subpart D. Issued under section 510(m)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(m)(2)), the order removes the prior exception that excluded devices intended for Federal drug testing programs—such as programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military—from existing employment and insurance testing 510(k) exemptions.

Regulatory Background and the 14 Amended Device Classifications

When the FDA previously finalized partial 510(k) exemptions for these 14 clinical toxicology device types in July 2017 (82 FR 31976, under section 510(m)(1) of the FD&C Act) and codified them in December 2019 (84 FR 71794), the exemption was restricted to test systems intended solely for employment and insurance testing and excluded devices intended for Federal drug testing programs. Following a 1 May 2026 notice of intent (91 FR 23427) under section 510(m)(2) of the FD&C Act and input from approximately 70 commenters, the FDA finalized the removal of the Federal drug testing program carve-out without modification on 6 October 2026.

Newly exempt devices transition from their legacy non-exempt product codes to the corresponding 510(k)-exempt product codes (PUX through PVK) listed in Table 1 of the Final Order (91 FR 63484–63485, with the codified amendments at 91 FR 63486–63487):

Partial Limitations, Labeling Rules, and General Limitations Under 21 CFR 862.9

The Final Order preserves strict partial and general limitations that determine when a clinical toxicology assay still requires 510(k) clearance:

1. Employment and insurance testing intended-use and labeling limitation: Under the amended paragraph (b) of all 14 regulations, a test system is not exempt if it is intended for any use other than employment or insurance testing (such as clinical diagnostic evaluation or medical treatment in healthcare settings). To qualify for the exemption, the device must be intended for employment and insurance testing and its labeling must include a statement that the device is intended solely for use in employment and insurance testing (FDA Response 11 notes that no single verbatim phrasing is mandated, provided that sole intended use is stated).
2. No enforcement discretion for legacy "not for Federal drug testing" labels (Response 12): Commenters asked the FDA to exercise enforcement discretion for previously 510(k)-exempt employment and insurance assays whose existing labels state that the device is not intended for use in Federal drug testing programs. The FDA explicitly declined this request, stating that all devices—whether 510(k)-exempt or not—must comply with 21 CFR Parts 801 and 809, including the requirement that labeling not be false or misleading.
3. General limitations of exemption under 21 CFR 862.9 (Response 2 & Section IV.A): Even if intended solely for employment and insurance testing (including Federal drug testing programs), a test system within the 14 regulations still requires a 510(k) if it exceeds any limitation in 21 CFR 862.9, including when:
   • The device is intended for a use different from the intended use of a legally marketed device in that generic type (21 CFR 862.9(a));
   • The device operates using a different fundamental scientific technology than a legally marketed device in that generic type (21 CFR 862.9(b));
   • The device is intended for noninvasive testing as defined in 21 CFR 812.3(k) (21 CFR 862.9(c)(8)); or
   • The device is intended for near-patient testing (point of care) (21 CFR 862.9(c)(9)). Manufacturers uncertain whether a specific analyte, cutoff concentration, or methodology triggers 21 CFR 862.9 may submit a Section 513(g) Request for Information (21 U.S.C. 360c(g)).
4. Federal-program acceptance and devices outside the order (Responses 6–8): FDA does not decide whether oral-fluid or hair testing may be used in Federal drug testing programs. The order does not extend the exemptions to oral-fluid collection devices, phencyclidine (PCP) test systems or every test used by a federally certified laboratory.
5. Continuing FDA and SAMHSA / NLCP obligations (Responses 3, 13, and 14): Exempt test systems remain subject to FDA establishment registration, device listing, labeling (21 CFR Parts 801 and 809), Quality Management System Regulation (21 CFR Part 820), and Medical Device Reporting (MDR). Laboratories testing specimens for Federal drug testing programs remain subject to SAMHSA Mandatory Guidelines and National Laboratory Certification Program (NLCP) oversight.

Pure Global analysis: IVD manufacturers supplying laboratories that serve Federal drug testing programs should document eligibility against the applicable classification and all of § 862.9, align the labeling with the actual intended use, and update device listing to the corresponding exempt product code. Resolve any legacy Federal-use exclusion before marketing for that use, while retaining the sole employment-and-insurance intended-use statement. Separately verify the receiving program's accepted specimen types, methods and laboratory requirements; an FDA 510(k) exemption does not establish program acceptance. The US market guide explains registration and listing in the wider FDA framework.