Skip to main content

Biomedical Engineering: FDA Regulations

General guide to resources for biomedical engineering.

Medical Devices Pathway to Market

FDA Regulatory Process

Medical Devices Registration

Medical devices marketed in the United States are subject to the regulatory controls in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts 1-58, 800-1299.

1. Determine whether the product is a medical device or a radiation-emitting product as defined by the FD&C Act, or both.

2. Determine device classification

3. Determine applicable regulatory controls

4. Register with FDA

Choose the Correct Premarket Submission for your Medical Device

Premarket Notification 510(k) - 21 CFR Part 807 Subpart E

Premarket Approval (PMA) - 21 CFR Part 814

Investigational Device Exemption (IDE) - 21CFR Part 812

Humanitarian Device Exemption​

Evaluation of Automatic Class III Designation (De Novo) Summaries

For more information, see: