FDA Regulations — 21 CFR
FDA medical device regulations are in Title 21 of the Code of Federal Regulations.
Key Parts
| Part | Title |
|---|---|
| 21 CFR Part 801 | Labeling |
| 21 CFR Part 803 | Medical Device Reporting (MDR) |
| 21 CFR Part 806 | Corrections and Removals |
| 21 CFR Part 807 | Establishment Registration and Device Listing |
| 21 CFR Part 812 | Investigational Device Exemptions (IDE) |
| 21 CFR Part 814 | Premarket Approval (PMA) |
| 21 CFR Part 820 | Quality Management System Regulation (QMSR) |
| 21 CFR Part 830 | Unique Device Identification (UDI) |
Quality System Regulation Update (2024)
FDA updated 21 CFR Part 820 in 2024 to align with ISO 13485:2016, creating the Quality Management System Regulation (QMSR).
- Effective: February 2, 2026
- Incorporates ISO 13485:2016 by reference
- Federal Register Notice
TIP
All 21 CFR regulations: ecfr.gov