Predicate Search
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Frequently Asked Questions

What is Predicate Search?

Predicate Search is a tool that allows you to search through FDA data to find predicates for your medical device.

How do I use the 510(k) search?

You can use the 510(k) search to find predicates by entering relevant keywords or phrases related to your device.

What is PMA?

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

What is De Novo classification?

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.