Predicate Search is a tool that allows you to search through FDA data to find predicates for your medical device.
You can use the 510(k) search to find predicates by entering relevant keywords or phrases related to your device.
Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
The De Novo request provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use.