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 dateChanges after registration in United States
Source-linked rules for common changes to a registered medical device. Read the scope and conditions with each rule; unverified details are listed separately.
Does changing a device brand name or logo require an update?
A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.
A source-verified answer for this specific scenario is not yet published.
How do I update a manufacturer's name without changing the legal entity?
The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.
A source-verified answer for this specific scenario is not yet published.
What changes when the manufacturer's office address changes?
An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.
A source-verified answer for this specific scenario is not yet published.
Does a catalogue or reference code change affect registration or UDI?
Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.
A source-verified answer for this specific scenario is not yet published.
Can a registration transfer to a different legal entity?
A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.
A source-verified answer for this specific scenario is not yet published.
Can several changes be filed together?
Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.
A source-verified answer for this specific scenario is not yet published.
What 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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