FDA Publishes Staff Guidance on De Novo Classification and Evaluation Class III Devices

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The purpose of this document is to provide guidance on the process for the submission and review of petitions under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), also known as the de novo classification process. This process provides a route to market for medical devices that are low to moderate risk, but that have been classified in class III because FDA has found them to be “not substantially equivalent” (NSE) to legally marketed predicate devices.

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