This resource is the version of US Title 21 of the Code of Federal Regulations, Part 820 (21 CFR Part 820), as of 11 September 2024 – the medical device Quality System Regulation (QSR).
About this document
Please note: the FDA has published a final rule amending 21 CFR Part 820 into the Quality Management System Regulation (QMSR) based on ISO 13485:2016, effective 2 February 2026. This resource can be used to compare the former QSR with the new QMSR; for current compliance requirements, please refer to the current version of the QMSR published by the FDA.
Applicable products and users
- Medical device manufacturers marketing in the US (including foreign manufacturers)
- Quality management staff transitioning from the QSR to the QMSR
Main contents
- Former QSR requirements on design controls, purchasing controls, and production and process controls
- Corrective and preventive action (CAPA), complaint handling and records requirements
- Can serve as the baseline text for a QSR→QMSR gap analysis
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Note: this resource is for reference only. Please refer to the latest official version published by the issuing authority.