Keyword Analysis & Research: fda 510k pathway

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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).

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.

What is the FDA accelerated approval pathway?

Accelerated approval is an expedited regulatory pathway that allows a drug to be approved by the US Food and Drug Administration (FDA) based on an endpoint (such as tumor shrinkage) that is considered “reasonably likely to predict a clinical benefit” (such as increased overall survival).

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