Standards · Standard or regulation
FDA 21 CFR 820 (QMSR)
US Quality Management System Regulation for medical devices
In plain words
What it covers.
The US federal rule that sets quality system requirements for medical device makers. Since February 2026 it is the Quality Management System Regulation (QMSR), which incorporates ISO 13485 by reference. Its earlier version, the Quality System Regulation, contained the well-known design controls of section 820.30. The FDA inspects manufacturers against it.
Who uses it: Manufacturers selling devices in the United States, their quality teams and suppliers.
A summary written by BMEssentia for learning, not the text of the standard. Always work from the current official edition and the manufacturer's instructions.
It covers
- Design controls
- Document and record control
- Purchasing controls
- Production and process controls
- Complaint handling
- Corrective and preventive action
- FDA inspection
Key points
What engineers need to know.
- Design controls (formerly 820.30) require planning, inputs, outputs, review, verification, validation and transfer.
- The design history file shows the design was developed under control.
- The QMSR aligns US rules with ISO 13485:2016.
- Complaints must be reviewed and, where needed, reported to the FDA as medical device reports.
- FDA inspection findings are issued on Form 483 and can lead to warning letters.
- Validation proves the device meets user needs; verification proves outputs meet inputs.
Medical City
Where you practise it.
- Design Studio design inputs and traceability (ISO 13485 7.3 via the QMSR, formerly 21 CFR 820.30)
- Design Studio design review