Regulayer™ / The 156 laws / Pharma & life sciences
FDA · QMSR (21 CFR 820)
Medical-device control of records.
What the signed record shows
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Citation: 21 CFR 820.35; ISO 13485:2016 Cl. 4.2.5
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What to do about it
Keep the evidence this asks for, as the work happens.
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What the statute requires, section by section
U.S. FDA, Quality Management System Regulation (QMSR), 21 CFR Part 820, effective 2 February 2026. The revised Part 820 incorporates ISO 13485:2016 (Medical devices, Quality management systems, Requirements for regulatory purposes) by reference, replacing most of the former Quality System Regulation text. Provisions this mapper evidences from the per-event signed record:
- ISO 13485:2016, Clause 4.2.5
- Control of records: records established and maintained to provide evidence of conformity and effective operation; records kept legible, identifiable and retrievable, and protected.
- 21 CFR 820.35
- Control of records: in addition to ISO 13485:2016 Clause 4.2.5, requires records for complaint and servicing activities (cf. 21 CFR
- Part 803), documentation for Unique Device Identification (21 CFR Part
- 830), and confidentiality of records sent to/received from FDA.
Taken from the Regulayer™ entry for this instrument, which is built against the primary text.