Quality Management System Regulation (21 CFR Part 820)

FDA · In force

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Summary

The amended US device quality system regulation, which incorporates ISO 13485:2016 by reference. It took effect on 2 February 2026 and is the regulatory basis for FDA's computer software assurance guidance.

Dated events

1. 2 Feb 2026 Took effect Source for Took effect

Official source

Official text

Source: FDA. Public domain.