FDA's QMSR FAQ: what manufacturers need to know

Key point: The amended 21 CFR Part 820, now the Quality Management System Regulation (QMSR), took effect on 2 February 2026. On the same day FDA stopped using its long-standing QSIT inspection technique and moved to a new inspection process. Internal audit, supplier audit and management review reports, previously exempt from inspection, are now in scope.

1. What changed?

The amended 21 CFR Part 820 is now titled the Quality Management System Regulation (QMSR), effective 2 February 2026.

At its core, the amendment incorporates by reference the quality management system requirements of ISO 13485:2016, the international standard for medical device quality management systems. FDA has determined that the requirements of ISO 13485 are, when taken in totality, substantially similar to those of the QS regulation and provide a similar level of assurance in a firm’s quality management system and its ability to consistently manufacture devices that are safe, effective and otherwise compliant with the FD&C Act.

The rule also renames the regulation and adds requirements that clarify certain expectations and concepts used in ISO 13485, so that incorporating the standard does not conflict with other applicable FDA requirements.

FDA also made conforming amendments to 21 CFR Part 4 to clarify device QMS requirements for combination products. These do not change the CGMP requirements for combination products.

FDA presents the change as part of its ongoing effort to align its regulatory framework with international ones, promoting consistency in device regulation and getting safe, effective, high-quality devices to patients faster.

2. A new inspection process

This is the part of the FAQ with the most practical impact.

On 2 February 2026, FDA stopped using the Quality System Inspection Technique (QSIT) for device inspections and moved to the inspection process described in the updated compliance program Inspection of Medical Device Manufacturers: 7382.850.

Note: From 2 February 2026, FDA no longer uses these two documents:

• Inspection of Medical Device Manufacturers (7382.845)
• Medical Device PMA Preapproval and PMA Postmarket Inspections (7383.001)

The new compliance program took effect on 2 February 2026 and was posted on FDA’s device compliance program page no later than the QMSR effective date.

Key clarification: In inspections on or after the QMSR effective date, FDA investigators may review records that are part of a manufacturer’s QMS, including records created before 2 February 2026. As FDA explains in the preamble to the final rule, the QS regulation and QMSR requirements are substantially similar, and manufacturers may conduct some form of comparison to show that documents and records created before the effective date meet QMSR requirements.

3. The FAQ, summarized

1. Why is FDA taking this action? FDA is committed to advancing and continually improving the quality, safety and effectiveness of medical devices to meet patient needs. The action harmonizes key areas of manufacturers’ quality management systems and brings the US closer to many other regulators worldwide.

2. How has FDA prepared for harmonizing the QS regulation with ISO 13485? FDA planned a range of implementation activities: updating IT systems; training FDA staff who assess device QMS compliance; developing the inspection process; revising related regulations and other documents affected by the rulemaking; and communicating with and educating stakeholders, including affected FDA staff.

3. What training will FDA staff receive? Training on the final rule, the revised inspection process and related changes to policies and procedures. FDA will also continue internal quality management system training so staff are familiar with QMS concepts and requirements.

4. How will the rule affect FDA staff and programs? FDA will continue to ensure devices are safe and effective, including through inspections, which incorporate the final rule’s requirements from the effective date. The rule also affects FDA’s internal training, and FDA plans to update its procedures, processes and policies to reflect it.

5. FDA incorporates ISO 13485:2016 by reference. What happens if the standard is revised? FDA will evaluate any future revision to determine its impact and whether QMSR should be amended. Where appropriate, amendments to QMSR will be made through rulemaking.

6. When does the new regulation take effect? On 2 February 2026, two years after publication in the Federal Register. FDA will begin enforcing QMSR requirements.

7. Which records does FDA intend to review in inspections on or after 2 February 2026? To help determine QMSR compliance, investigators may review records that are part of the manufacturer’s QMS, including records created before 2 February 2026. As the preamble notes, QS regulation and QMSR requirements are substantially similar. Manufacturers may find it useful to conduct some form of comparison to show that documents and records created before the effective date meet QMSR requirements.

8. Will FDA review records that were exempt under QS regulation § 820.180(c), such as internal audit, supplier audit and management review reports? Yes. QMSR gives FDA authority to inspect management review, quality audit and supplier audit reports. The exception in § 820.180(c) was not retained. As the preamble explains, because manufacturers already have to provide these documents to other regulators, providing them to FDA investigators is not an additional burden. These records are kept in the normal course of business and should be readily available during an inspection.

9. Is there a new inspection process? Yes. FDA has implemented a new inspection process aligned with QMSR. On 2 February 2026 QSIT was withdrawn and the process described in the updated compliance program 7382.850 took effect.

10. Where can I find information on the new QMSR inspection process? In the updated compliance program Inspection of Medical Device Manufacturers: 7382.850, on FDA’s CDRH Compliance Programs page.

11. How should manufacturers prepare for FDA inspections on or after 2 February 2026? The best preparation is to meet the FDA requirements that apply to your FDA-regulated products. For inspections on or after the QMSR effective date, FDA recommends being ready to discuss and provide records showing compliance with QMSR.

12. How can manufacturers access ISO 13485:2016 and clause 3 of ISO 9000:2015? Read-only versions are available through the American National Standards Institute (ANSI) incorporated by reference (IBR) portal and the ISO Online Browsing Platform. See the QMSR final rule, 89 FR 7496, at 7500.

13. How do FDA inspections under QMSR compare with MDSAP audits? Three key differences:

• FDA inspections under QMSR do not follow MDSAP audit plans or procedures.
• FDA does not require, and does not issue, ISO 13485 certificates. Holding an ISO 13485 certificate does not exempt a manufacturer from FDA inspection (see FDA’s responses to comments 79, 80 and 81 in the final rule).
• They differ in nature: FDA inspections assess compliance with FDA regulations and are scheduled based on risk; third-party audits assess conformity to a standard and run annually on a three-year cycle.

MDSAP remains a voluntary third-party audit program, open to manufacturers that choose to take part.

4. Our reading

The key change is not that ISO 13485 is incorporated. It is that the records exemption is gone.

FAQ 8 is the one to highlight. The exemption in § 820.180(c) for internal audit, supplier audit and management review reports is explicitly not retained in QMSR. FDA’s reasoning is simple: you already give these to other regulators, so showing them to FDA is no extra burden.

“Kept in the normal course of business and readily available during an inspection” has a practical meaning: these three types of records must be ready to hand over at any time. “It’s an internal document” is no longer a reason to hold them back.

Second, watch how records from before the transition are handled.

FDA says plainly that it will review records created before 2 February 2026. The room it leaves you is the qualifier “part of the manufacturer’s QMS,” and the suggestion to prepare a comparison showing that older records meet QMSR requirements. Note that the FAQ says manufacturers “may find it useful”: a recommendation, not a requirement.

Third, do not confuse QMSR with MDSAP.

FAQ 13 is clear. QMSR inspections do not follow MDSAP audit plans; FDA neither requires nor issues ISO 13485 certificates; and a certificate does not exempt you from inspection. MDSAP continues as a voluntary program, but it and FDA inspection follow different logic: one checks compliance with regulations, the other conformity to a standard.

Finally: the standard itself will change.

FAQ 5 says that FDA will assess any future revision of ISO 13485 and, if needed, amend QMSR through rulemaking. QMSR is a living regulation, not a one-time change.

Sources

• This article is based on FDA’s Quality Management System Regulation – Frequently Asked Questions (updated 6 November 2026). The FAQ answers above are our summary; refer to FDA’s page for the exact wording.
• Background: On 31 January 2024 FDA published a final rule amending the device CGMP requirements in 21 CFR Part 820 to align them more closely with the international standard for medical device quality management systems. The rule incorporates ISO 13485:2016 by reference and renames Part 820 the QMSR. It took effect two years after publication, on 2 February 2026.
• Inspection of Medical Device Manufacturers Compliance Program: 7382.850 (updated)
• QMSR final rule, 89 FR 7496
• AAMI/ISO 13485:2016 practical guide; AAMI TIR102:2019 (mapping between 21 CFR and ISO 13485:2016)

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This article is general information, not regulatory or legal advice for a specific device. Requirements change; check the official sources and the date above.