US FDA QMSR Consulting for Medical Devices

FDA QMSR is now in effect

The US Food and Drug Administration Quality Management System Regulation (QMSR) became effective on February 2, 2026. It amended the device current good manufacturing practice requirements in 21 CFR Part 820 and incorporated ISO 13485:2016 by reference, together with ISO 9000:2015 Clause 3 for terms and definitions. The former Quality System Regulation language should no longer be described as the current framework.

QMSR harmonizes much of FDA's system with the international medical device QMS standard, but it is not satisfied merely by holding an ISO 13485 certificate. Manufacturers remain responsible for the FDA-specific provisions in Part 820 and other applicable requirements, including complaint handling, Medical Device Reporting, corrections and removals, UDI, and records. FDA can inspect for compliance regardless of whether a certification body has issued a certificate.

What manufacturers should verify

A practical QMSR assessment should map the organization's procedures and records to the incorporated standard and FDA additions. Priority areas include:

• risk-based quality planning across the product lifecycle;
• design and development controls for applicable devices, including software validation;
• supplier qualification and outsourced-process controls;
• production, process validation, cleanliness, packaging, and labeling controls;
• complaint investigation and escalation into MDR, corrections, removals, and CAPA;
• management review, internal audits, quality records, and inspection readiness; and
• controls for combination products and other product-specific requirements.

The assessment should be scoped to the legal manufacturer and each site or contractor performing regulated activities. Gaps need owners, evidence, and completion dates rather than a policy-only cross-reference.

FDA inspections under QMSR

FDA stopped using the Quality System Inspection Technique (QSIT) on February 2, 2026. Device inspections now use the process described in Compliance Program 7382.850. Records that previously received special limits under the former regulation, including management review, quality-audit, and supplier-audit reports, may be reviewed under QMSR. Inspection preparation should therefore include record availability, staff readiness, and evidence that the quality system operates in practice.

Maintaining compliance

QMSR work is not a one-time conversion project. New products, suppliers, sites, software releases, complaints, regulatory changes, and acquisitions can alter the compliance state. Manufacturers should incorporate QMSR impact checks into design changes, supplier changes, CAPA, management review, and internal-audit programs, and keep the FDA establishment, listing, submission, and post-market obligations aligned with the same controlled quality records.