FDA Q&A Document on the new GMP Regulations for Medical Devices

On 2 February 2026, the GMP rules for medical devices in the US changed significantly. Whereas the Quality System Regulations (QSR) had been the binding rules since the 1990s, inspected by the FDA using the Quality System Inspection Technique (QSIT), the rules have now changed to the Quality Management System Regulations (QMSR). For medical device manufacturers, this meant a much greater integration of ISO 13485 than before. And this also has an impact on the GMP regulations for combination products (21 CFR 4). To provide guidance on this change, the FDA has published a 'Frequently Asked Questions' document. It provides concise answers to 13 questions. What does it contain? Below are a few selected questions and answers.

Question 1 is: Why is the FDA changing its rules? The answer is relatively simple and welcome: the FDA views this as harmonisation with other regulations around the world. Naturally, this is accompanied by continued improvements in the quality, safety and effectiveness of medical devices.

Question No. 5 is also very interesting: What happens to the US rules if ISO 13485:2016 is revised? The answer: The FDA will critically assess changes to ISO 13485:2016 and, where necessary, implement adjustments via the traditional route used to amend GMP regulations.

Question 7 is also interesting: which records will the FDA review after 2 February 2026? The answer to these questions is: it will examine reports that were still prepared in accordance with the old QMS regulations, but also those prepared in accordance with the new QMSR regulations. It recommends that manufacturers carry out a comparative analysis of documents between QMS and QMSR regulations. In principle, the FDA regards both sets of regulations as comparable.

Question 8 is also very interesting: will the FDA, after 2 February 2026, review reports that previously fell under an exemption (21 CFR 820.180(c)), such as internal audits, supplier audits and management review documents? The answer is now quite succinct: yes, as this provision no longer exists. Furthermore, the FDA even recommends keeping these reports available during an inspection.

And how does a medical device manufacturer access the QMSR-based standards ISO 13485:2016 and ISO 9000:2015, sentence 3 (Question 12)? Both standards can be viewed in a 'read-only' format on the American National Standards Institute (ANSI) portal.

Conclusion: With the introduction of the Quality Management System Regulations on 2 February 2026, there will be significant changes for both medical device manufacturers and manufacturers of combination products during an FDA inspection. Among other things, self-inspection reports, supplier evaluations and management reviews may now also be subject to inspection.

You can find the Q&As on the FDA website.