What are the main FDA medical device regulations?
The principal FDA medical-device requirements cover establishment registration, device listing, premarket authorization, quality systems, labeling, adverse-event reporting, recalls, clinical investigations, and unique device identification. The applicable requirements depend on the device classification and intended use.
Answer
U.S. medical devices are governed by the Federal Food, Drug, and Cosmetic Act and implementing regulations in Title 21 of the Code of Federal Regulations.
Important medical-device parts include:
• 21 CFR Part 11: Electronic records and electronic signatures
• Part 801: Medical-device labeling
• Part 803: Medical Device Reporting
• Part 806: Corrections and removals
• Part 807: Establishment registration, device listing, and 510(k) submissions
• Part 812: Investigational Device Exemptions
• Part 814: Premarket Approval and related pathways
• Part 820: Quality Management System Regulation
• Part 821: Medical-device tracking
• Part 822: Post-market surveillance
• Part 830: Unique Device Identification
Clinical studies may also involve 21 CFR Parts 50 and 56 governing informed consent and institutional review boards. Radiation-emitting electronic products can be subject to additional requirements under Parts 1000–1050. Combination products and in vitro diagnostic devices may have further requirements.
Compliance begins with the device’s intended use, classification, product code, and applicable classification regulation. General controls apply broadly, while Class II devices may have device-specific special controls. Class III devices generally require PMA approval.
FDA guidance documents and recognized consensus standards help explain acceptable approaches, but guidance is not identical to binding regulation. Manufacturers should create a product-specific regulatory matrix rather than treating every CFR part as equally applicable.
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