RAPath US
FDA Medical Device Regulatory Reference
RAPath US is a plain English reference for FDA medical device regulation under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR. It is designed for regulatory affairs professionals, manufacturers, importers, distributors, and consultants who need to find and understand FDA requirements quickly.
This site does not replace official FDA sources. Every page links back to the authoritative legislative text or official FDA guidance. Think of RAPath US as a structured, searchable index that helps you find what you need — then points you to the official source to verify it.
Who this site is for
Regulatory affairs professionals and consultants — a well-structured reference for requirements you navigate daily, with every claim linked to its legislative source.
Manufacturers (US and overseas) — understand what the FDA requires of you, and how it relates to frameworks you may already know (EU MDR, TGA, Health Canada).
Importers and distributors — understand your establishment registration, device listing, and post-market obligations in the US.
Anyone new to FDA medical device regulation — start with Start Here for a guided introduction to the framework.
How to use this site
The site is structured around the regulatory lifecycle of a medical device in the USA:
| Section | What it covers |
|---|---|
| Start Here | Definitions, framework overview, who needs to comply, device lifecycle |
| Pre-Market | Classification, 510(k), De Novo, PMA, clinical evidence, special device types |
| Post-Market | MDR, recalls, 522 studies, labelling and advertising |
| Quality System (QMSR) | 21 CFR Part 820, design controls, CAPA, FDA inspections |
| Establishment, Listing & UDI | Annual registration, device listing, foreign establishments, UDI |
| Legislation & Regulations | FD&C Act, 21 CFR parts, FDASIA, MDUFA |
| Guidance Documents | FDA guidance index, eSTAR templates, MDUFA timelines |
| Special Access & Designations | Breakthrough, HDE, EUA, Expanded Access |
| International & Comparison | IMDRF, FDA vs TGA/EU/HC/HSA, multi-market strategy |
| Enforcement & Compliance | Warning letters, 483s, consent decrees |
| Digital Health & SaMD | SaMD, AI/ML, CDS policy, PCCPs |
| What's New | Recent changes, draft guidance, open dockets |
What this site is not
- Not legal or regulatory advice. Always consult qualified regulatory counsel before making submission or compliance decisions.
- Not affiliated with FDA. This site is not produced by or on behalf of the U.S. Food and Drug Administration.
- Not a substitute for official sources. Every page links to the relevant FDA guidance, 21 CFR section, or FD&C Act provision — always verify there.
Content currency
This site was last reviewed in May 2026. FDA guidance and regulations change frequently. Check What's New for recent updates.
Content on this site is written with AI assistance and is intended as a navigation aid only. Always verify against official FDA sources before making regulatory decisio