Applicability
Finished medical-device manufacturers and others within the scope of 21 CFR Part 820.
What Changed
Revised Part 820 is titled QMSR and incorporates ISO 13485:2016 by reference. FDA began using the updated inspection process on the effective date.
What Did Not Change
Manufacturers remain responsible for applicable FD&C Act and FDA requirements. A certificate or generic standards claim does not establish software fitness for a particular use.
Practical Impact
Connect computerized-system validation evidence to the QMS process supported and review procedures, references, supplier controls, and inspection records for QMSR alignment.
Actions to Consider
Use the current rule and FDA implementation material to complete a documented, process-specific assessment.
Primary Source
Revision history
Version 1.2 · 12 September 2026: Terminology and source fields standardized for Version 32.