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21 CFR: FDA regulations
1,363 sections of Title 21 for drugs, biologics, devices and clinical research. Each one comes with the Form 483 observations and warning letters that cite it, and the FDA guidance that explains it.
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work
in the public domain. Inspection data comes from the FDA Data Dashboard, which does not include
every inspection; an observation is not a final finding of a violation. Compliome is not affiliated
with or endorsed by FDA. Not legal advice.
General, records and electronic signatures
- Part 3 Product Jurisdiction 10 §
- Part 4 Regulation of Combination Products 10 §
- Part 11 Electronic Records; Electronic Signatures 10 §
Clinical research and human subjects
- Part 50 Protection of Human Subjects 15 §
- Part 54 Financial Disclosure by Clinical Investigators 6 §
- Part 56 Institutional Review Boards 20 §
- Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies 36 §
- Part 312 Investigational New Drug Application 60 §
- Part 812 Investigational Device Exemptions 32 §
Drugs: labelling, GMP and applications
- Part 201 Labeling 74 §
- Part 202 Prescription Drug Advertising 1 §
- Part 203 Prescription Drug Marketing 22 §
- Part 206 Imprinting of Solid Oral Dosage Form Drug Products for Human Use 4 §
- Part 207 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and the National Drug Code 24 §
- Part 209 Requirement for Authorized Dispensers and Pharmacies to Distribute a Side Effects Statement 4 §
- Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General 3 §
- Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals 60 §
- Part 212 Current Good Manufacturing Practice for Positron Emission Tomography Drugs 16 §
- Part 216 Human Drug Compounding 2 §
- Part 225 Current Good Manufacturing Practice for Medicated Feeds 20 §
- Part 226 Current Good Manufacturing Practice for Type a Medicated Articles 11 §
- Part 250 Special Requirements for Specific Human Drugs 9 §
- Part 299 Drugs; Official Names and Established Names 3 §
- Part 300 General 3 §
- Part 314 Applications for FDA Approval to Market a New Drug 68 §
- Part 316 Orphan Drugs 24 §
- Part 320 Bioavailability and Bioequivalence Requirements 19 §
Biologics, blood and tissues
- Part 600 Biological Products: General 15 §
- Part 601 Licensing 39 §
- Part 606 Current Good Manufacturing Practice for Blood and Blood Components 17 §
- Part 607 Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices 16 §
- Part 610 General Biological Products Standards 28 §
- Part 630 Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use 10 §
- Part 640 Additional Standards for Human Blood and Blood Products 61 §
- Part 660 Additional Standards for Diagnostic Substances for Laboratory Tests 31 §
- Part 680 Additional Standards for Miscellaneous Products 3 §
- Part 1271 Human Cells, Tissues, and Cellular and Tissue-Based Products 49 §
Medical devices
- Part 801 Labeling 38 §
- Part 803 Medical Device Reporting 26 §
- Part 806 Medical Devices; Reports of Corrections and Removals 6 §
- Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices 24 §
- Part 810 Medical Device Recall Authority 13 §
- Part 814 Premarket Approval of Medical Devices 33 §
- Part 820 Quality Management System Regulation 35 §
- Part 821 Medical Device Tracking Requirements 10 §
- Part 822 Postmarket Surveillance 37 §
- Part 830 Unique Device Identification 20 §
- Part 860 Medical Device Classification Procedures 23 §
- Part 862 Clinical Chemistry and Clinical Toxicology Devices 263 §