USA Medical Device Regulations
USA Medical Device Regulations
All documents listed below were published by the US Food and Drug Administration (FDA). Please help us maintain this list by reporting outdated or missing documents. If you need help determining the regulatory requirements for your medical device in the United States, you may be interested in our custom regulatory strategy reports for the United States.
US FDA Code of Federal Regulations
- 21 CFR Part 11 - Electronic Records; Electronic Signatures
- 21 CFR Part 801 - Labeling
- 21 CFR Part 803 - Medical Device Reporting Or download PDF.
- 21 CFR Part 806 - Reports Of Corrections And Removal. Or download PDF
- 21 CFR Part 807 - Establishment Registration. Or download PDF
- 21 CFR Part 809 - In Vitro Diagnostic Products For Human Use
- 21 CFR Part 812 - Investigational Device Exemptions
- 21 CFR Part 820 - Quality System Regulation. Or download PDF.
- 21 CFR Part 821 - Medical Device Tracking Requirements. Or download PDF.
- 21 CFR Part 822 - Postmarket Surveillance
- 21 CFR Part 860 - Medical Device Classification Procedures