United States medical device regulations
Official sources linkedFDA rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| 21 CFR Part 820 | Quality Management System Regulation Current eCFR Part 820 Quality Management System Regulation. Official XML ingested from the eCFR versioner using the title 21 up-to-date-as-of date, not ingest time. | GMP/QMS | February 2, 2026 | Official |
| 21 CFR Part 830 | Unique Device Identification Current eCFR Part 830 unique device identification requirements. | UDI | September 24, 2013 | Official |
| 21 CFR Part 801 | Labeling Current eCFR Part 801 labeling requirements for medical devices. | Labeling | — | Official |
| 21 CFR Part 803 | Medical Device Reporting Current eCFR Part 803 medical device reporting requirements. | Vigilance | — | Official |
| 21 CFR Part 807 | Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices Current eCFR Part 807 establishment registration, device listing, and premarket notification procedures. Subpart E is a virtual view of this same part. | Registration | — | Official |
| 21 CFR Part 807 Subpart E | Premarket Notification Procedures Virtual view of Part 807 Subpart E (510(k) premarket notification). The official text is ingested once with Part 807. | Registration | — | Official |
| 21 CFR Part 809 | In Vitro Diagnostic Products for Human Use Current eCFR Part 809 in vitro diagnostic product requirements. | Labeling | — | Official |
| 21 CFR Part 812 | Investigational Device Exemptions Current eCFR Part 812 investigational device exemption requirements. | Clinical Trials | — | Official |
| 21 CFR Part 814 | Premarket Approval of Medical Devices Current eCFR Part 814 premarket approval procedures. | Registration | — | Official |
| 21 CFR Part 860 | Medical Device Classification Procedures Current eCFR Part 860 classification procedures, including De Novo. | Classification | — | Official |
| FDA Product Classification Database | FDA Product Classification Catalogue Official openFDA Product Classification dataset: 7,091 unique product codes with device name, class or unclassified reason, definition, medical specialty, regulation number, implant flag, and life-sustain/support flag. | Classification | — | Official |
Exports carry source + retrieval dateWhat these codes are
Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.
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