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Frequently Asked Questions

Who is required by the FDA to file a 510k?

Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510 (k) to FDA...

What is 510K FDA approval?

FDA 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA).

What is 510 approval FDA?

A 510 (K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513 (i) (1) (A) FD&C Act) that is not subject to premarket approval. Learn more...

What is the FDA Database?

The FDA Adverse Event Reporting System (FAERS) database contains information on adverse event and medication error reports submitted to FDA. The database is designed to support the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products.


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