What does FDA · QMSR (21 CFR 820) cover?

Medical-device control of records. It applies to: Medical-device makers (US).

What does the Regulayer pack for FDA · QMSR (21 CFR 820) prove?

A tamper-evident, attributable control-of-records trail for device quality records. The record is signed and tamper-evident, and anyone can verify it free, without an account.

Regulayer / The 146 laws / Pharma & life sciences

FDA · QMSR (21 CFR 820)

Medical-device control of records.

Instrument: Regulation, legally bindingApplies to: Medical-device makers (US). Built · in force Feb 2026

What the signed record shows

A tamper-evident, attributable control-of-records trail for device quality records.

The proof is a signed, tamper-evident record. Anyone can check it, free, without an account, and nothing has to leave the building to make it. Evidence, not a promise.

Citation: 21 CFR 820.35; ISO 13485:2016 Cl. 4.2.5

In the same family

FDA · 21 CFR Part 11Electronic records & signatures EU GMP · Annex 11Computerised-systems integrity FDA-EMA · Good AI Practice (Jan 2026)Data governance, performance, life-cycle management

What to do about it

Keep the evidence this asks for, as the work happens.

A consequential AI-proposed action is checked against the human authority in force at that moment, and the decision leaves a signed record that a third party can verify independently, offline, without Regulayer. It runs inside your own environment and nothing has to leave it.

Life sciences: how the control works Or verify a real record, free →

Part of the Regulayer proof catalogue: 146 laws and standards, one sealed engine. This page is a product description, not legal advice.

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.