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), with most submissions governed by Parts 807–830 and device classification in Parts 862–892
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
Official resources
FDA Guidance Documents: FDA issues guidance documents (guidance for industry, guidance for reviewers) that explain how FDA interprets and applies regulations. Guidance is not legally binding but carries significant persuasive authority. FDA guidance can be found on the FDA website by product area or searched by topic at fda.gov/medical-devices/guidance-compliance-regulatory-information.