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 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: