FDA’s Quality Management System Regulation (QMSR) 

The 21 CFR Part 820 was updated on February 2, 2026, to the Quality Management System Regulation (QMSR).

This rule requires medical device manufacturers to maintain a quality system that ensures their products are safe and effective for the U.S. market.

What to expect:

Key changes include a mandatory risk-based approach throughout the product lifecycle, increased inspection authority for internal records, and updated terminology for key documents, while retaining specific U.S. requirements for labeling, reporting, and UDI (Unique Device Identification).

The FDA has replaced the traditional Quality System Inspection Technique (QSIT) with a new, risk-based inspection strategy.

Compliance

Manufacturers must demonstrate full compliance with the Quality Management System Regulation (QMSR) during an official FDA inspection.

Although the QMSR incorporates ISO 13485:2016 by reference, holding a third-party certificate for that standard does not satisfy FDA requirements or exempt you from federal inspections. However, by adopting ISO 13485:2016 standards, it streamlines global compliance for the entire product lifecycle from design and manufacturing to packaging, storage, and servicing.

Key points for compliance:

The new Compliance Program 7382.850 aligns with QMSR’s risk-based framework.

Under the new rule, the FDA now has the authority to inspect records that were previously exempt, including internal quality audits, management reviews, and supplier audit reports.

You must address additional U.S. requirements not found in ISO 13485, such as specific labeling and packaging controls under 21 CFR Part 820.45 (a specific section of the QMSR that covers the Control of Records).

Immediate Actions for Non-Compliant Firms

If your system has not yet been updated, you should prioritize the following:

Update Records: Transition legacy terms (DMR, DHR, DHF) to their ISO equivalents (Medical Device File, Medical Device Record, Design and Development File).

Be prepared to provide management reviews and internal/supplier audit reports, as these are no longer exempt from FDA inspection.

Ensure risk-based thinking is integrated throughout your entire product lifecycle, not just in design validation.

The new inspection process for QMSR:

The QMSR inspection process is described in the updated Inspection of Medical Device Manufacturers Compliance Program: 7382.850.

FDA device inspections:

• A certificate of conformance to ISO 13485 will not exempt a manufacturer from an FDA inspection.
• FDA inspections assess compliance with FDA regulations and are scheduled based on risk factors.
• MDSAP is a voluntary third-party audit program and will still be available to manufacturers who choose to participate.

Because the QMSR was built on international standards, 

A complete copy of the regulation consists of three separate parts:

• Federal Code (21 CFR Part 820): This contains the scope and “supplemental” U.S.-specific requirements (like labeling and complaint handling) that go beyond international standards.
• ISO 13485:2016: This is the core framework for the QMS, which the FDA now “incorporates by reference”. Read Only version.
• ISO 9000:2015 (Clause 3): This provides the mandatory definitions used within the regulation. Read Only version.

The FDA Compliance Program Manual titled “Inspection of Medical Device Manufacturers”, now officially designated CP 7382.850, was issued on January 30, 2026, and became effective on February 2, 2026. It coincides with the start of the Quality Management System Regulation (QMSR). CP 7382.850 is the operating manual for FDA investigators conducting inspections of medical device manufacturers under the QMSR.

• 7382.850 is the FDA’s official Compliance Program Manual.

To review the Final Rule dated 10/15/2024.