On January 21, 2024, the FDA issued a final rule amending its Quality System (QS) regulations under 21 CFR Part 820, which addresses current good manufacturing practice (CGMP) requirements for medical device manufacturers. The amendments are aimed at more closely harmonizing these requirements with ISO 13485:2016, which is the international consensus standard for Quality Management Systems, as well as terms and definitions from Clause 3 of ISO 9000:2015, with some narrow exceptions set forth in the new 21 CFR 820.3(b).
The revised Part 820 is now referred to as the Quality Management System Regulation (QMSR). FDA’s enforcement of the QMSR will begin on February 2, 2026.
In this alert, we discuss key takeaways from FDA’s final rule as well as important considerations for the EU and China, where the ISO standard has been adopted in varying degrees.
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