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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.

When is a 510k required?

A premarket notification (510(k)) is required when a legally marketed device subject to 510(k) requirements is significantly changed or modified in design, components, method of manufacture, or intended use.

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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