Regulatory pathway · all topics

FDA Quality System Regulation (21 CFR 820)

21 CFR Part 820 establishes current good manufacturing practice (CGMP) requirements for medical devices in the US. Sections include 820.30 Design Controls, 820.50 Purchasing, 820.70 Production and Process Controls, 820.100 CAPA, 820.180 Records. Final Rule of 31 January 2024 harmonizes QSR with ISO 13485:2016 with effective date of 2 February 2026, replacing QSR with the Quality Management System Regulation (QMSR). After that date, ISO 13485:2016 is incorporated by reference.

Source

FDA, '21 CFR Part 820 Quality System Regulation' and 'Quality Management System Regulation' Final Rule (Feb 2024)

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820

How MedTek OS handles this

Compass drafts the fda quality system regulation (21 cfr 820) workflow with confidence-gated content.

The platform refuses to generate content below the threshold for this artifact class. Every claim carries a citation chain back to RIG, audit-logged with HMAC integrity.

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