Some medical devices require premarket submissions depending on use and classification:
- Premarket Notification (510(k))- A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is safe and effective, and substantially equivalent to a legally-marketed device that is not subject to Premarket Approval. Visit our Premarket Notification 510(k) page for more information.
- Premarket Approval (PMA)- This is the FDA’s process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Visit our Premarket Approval page for more information.
