How to Read the CFR & Federal Register
The Code of Federal Regulations (CFR)
The CFR is the official codification of all permanent US federal regulations. It is divided into 50 Titles:
- Title 21 — Food and Drugs contains all FDA regulations
- Medical device regulations are in Title 21, Chapter I, Subchapter H (Parts 800–898)
CFR citation format
A CFR citation like 21 CFR § 820.100 means:
- 21 — Title 21 (Food and Drugs)
- CFR — Code of Federal Regulations
- § 820 — Part 820 (Quality Management System Regulation)
- .100 — Section 100 (Corrective and Preventive Action)
Where to access the CFR
| Source | URL | Notes |
|---|---|---|
| eCFR | ecfr.gov | Continuously updated; best for daily use |
| govinfo.gov | govinfo.gov | Official annual edition; legal benchmark |
| FDA website | fda.gov | Links to key sections with FDA commentary |
The Federal Register
The Federal Register is published every US government business day and contains:
| Type | Description |
|---|---|
| Proposed Rule (NPRM) | Draft regulation open for public comment (typically 60–90 days) |
| Final Rule | Regulation that has completed rulemaking and is effective on a stated date |
| Direct Final Rule | Final rule issued without prior proposed rule (for non-controversial changes) |
| Notice | Announcements — guidance issuances, public meetings, advisory committee notices |
The rulemaking process
FDA identifies need for regulation
↓
Draft NPRM (proposed rule) → published in Federal Register
↓
Public comment period (60–90 days)
↓
FDA reviews comments and revises
↓
Final Rule published in Federal Register
↓
Effective date (typically 30–60 days after publication)
↓
CFR is updated to reflect the final rule
Where to access the Federal Register
- federalregister.gov — best search interface
- govinfo.gov — official archive
Tips for navigating device regulations
- Start with the product classification database — find your product code, which tells you the applicable 21 CFR Part and section
- Use eCFR for current regulation text — it is continuously updated as regulations change
- Search the Federal Register by CFR Part to find the history of a regulation — including the original proposed rule and all amendments
- Sign up for FDA email alerts at FDA's subscription service to receive notifications when new guidance or rules are published for your device area