FDA Regulations — 21 CFR
FDA medical device regulations are in Title 21 of the Code of Federal Regulations (21 CFR). All regulations: ecfr.gov/current/title-21.
Key Parts Overview
| Part | Title | Key Requirement |
|---|---|---|
| 21 CFR 801 | Labeling | Adequate directions for use, Rx-only labeling |
| 21 CFR 803 | Medical Device Reporting (MDR) | Mandatory reporting of deaths, serious injuries, malfunctions |
| 21 CFR 806 | Corrections and Removals | Reporting recalls and field corrections |
| 21 CFR 807 | Establishment Registration & Device Listing | 510(k) premarket notification |
| 21 CFR 812 | Investigational Device Exemptions (IDE) | Clinical studies with unapproved devices |
| 21 CFR 814 | Premarket Approval (PMA) | Class III device approval |
| 21 CFR 820 | Quality Management System Regulation (QMSR) | QMS aligned with ISO 13485:2016 |
| 21 CFR 830 | Unique Device Identification (UDI) | UDI labeling and GUDID database |
21 CFR Part 820 — QMSR Key Requirements (Effective Feb 2, 2026)
FDA updated Part 820 in 2024 to align with ISO 13485:2016, creating the Quality Management System Regulation (QMSR).
- Federal Register Notice
- Incorporates ISO 13485:2016 by reference
- Replaces the former Quality System Regulation (QSR)
Key QMSR Subparts:
| Subpart | Topic |
|---|---|
| Subpart A | General Provisions (scope, definitions) |
| Subpart B | Quality Management System (QMS planning, documentation) |
| Subpart C | Management Responsibility |
| Subpart D | Resource Management |
| Subpart E | Product and Service Realization (design controls, purchasing) |
| Subpart F | Measurement, Analysis and Improvement |
21 CFR Part 801 — Labeling Key Sections
- 801.4: Adequate directions for use
- 801.15: Prominence of required label statements
- 801.109: Prescription devices — Rx-only labeling
- 801.119: In vitro diagnostic products labeling
21 CFR Part 812 — IDE Key Sections
- 812.20: Application for IDE
- 812.25: Investigational plan (protocol, risk analysis, device description)
- 812.36: Treatment IDE for serious/life-threatening conditions
Premarket Submission Pathways
| Pathway | Regulation | Device Class | Description |
|---|---|---|---|
| 510(k) | 21 CFR 807 Subpart E | Class II (most) | Substantial equivalence to predicate |
| De Novo | 21 CFR 860.260 | Class I/II (novel) | New classification for novel low-to-moderate risk devices |
| PMA | 21 CFR 814 | Class III | Premarket approval with clinical evidence |
| HDE | 21 CFR 814 Subpart H | Class III (rare disease) | Humanitarian Device Exemption |
| IDE | 21 CFR 812 | Investigational | Clinical study exemption |
TIP
All 21 CFR regulations: ecfr.gov/current/title-21