Quality System Regulation (QSR) for Medical Devices
Quality System Regulation governing the methods and facilities used in the design, manufacture, packaging, labelling, storage, installation, and servicing of all finished medical devices for human use. Now harmonised with ISO 13485:2016.
All manufacturers of finished medical devices intended for commercial distribution in the United States, regardless of the location of the manufacturing facility.
- 01Design controls including DHF, design input/output, design review, verification and validation
- 02CAPA subsystem with procedures for identifying, investigating, and correcting quality problems
- 03Purchasing controls — supplier qualification and ongoing oversight
- 04Production and process controls including process validation
- 05Device History Record (DHR) for each batch or production run
- 06Management with executive responsibility and quality planning
February 2022 update harmonises with ISO 13485:2016. Phased implementation through 2026. Manufacturers must comply with either old or new requirements during transition.
21 CFR Part 820: frequently asked questions
Quick answers to common questions about 21 CFR Part 820.
What is 21 CFR Part 820?
21 CFR Part 820 — Quality System Regulation (QSR) for Medical Devices — is a regulation issued by the Food and Drug Administration (United States). Quality System Regulation governing the methods and facilities used in the design, manufacture, packaging, labelling, storage, installation, and servicing of all finished medical devices for human use. Now harmonised with ISO 13485:2016.
Who does 21 CFR Part 820 apply to?
All manufacturers of finished medical devices intended for commercial distribution in the United States, regardless of the location of the manufacturing facility.
What are the key requirements of 21 CFR Part 820?
FDA 21 CFR Part 820 requires, among other things: Design controls including DHF, design input/output, design review, verification and validation; CAPA subsystem with procedures for identifying, investigating, and correcting quality problems; Purchasing controls — supplier qualification and ongoing oversight; Production and process controls including process validation.
When was 21 CFR Part 820 last updated?
The current version of 21 CFR Part 820 dates from February 2024. February 2022 update harmonises with ISO 13485:2016. Phased implementation through 2026. Manufacturers must comply with either old or new requirements during transition.
Ready-to-use templates designed to help you comply with 21 CFR Part 820.
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