Keyword Analysis & Research: 510k medical

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When do you need a 510k?

If you are planning to manufacture or distribute a medical device within the United States of America, the FDA requires (in most cases) that you complete either a 510k submission or obtain premarket approval for your medical device.

What is a 510 k medical device?

A 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 (21 CFR 807.92 (a) (3)) that is not subject to PMA.

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...

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