Summary
Final FDA rule amending the device current good manufacturing practice (CGMP) requirements in 21 CFR part 820 to harmonize with ISO 13485:2016 and related quality-management standards; the rule became effective February 2, 2026.
Healthcare Implications
Directly affects medical device manufacturers, including developers of AI-enabled devices and software, by changing quality-system, documentation, supplier-control, and inspection expectations. Health systems and vendors using AI devices should expect stronger lifecycle governance and compliance alignment.