Medical Devices; Rescission of Substantially Equivalent Decisions and Rescission Appeal Procedures

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The Food and Drug Administration (FDA) is proposing regulations under which FDA may rescind a decision issued under the Federal Food, Drug, and Cosmetic Act (the act) that a device is substantially equivalent to a legally marketed device, and, therefore, may be marketed. In addition, under this proposal, a premarket notification (commonly known as a "510(k)") holder may request administrative review of a proposed rescission action. This proposed rule is being issued in order to standardize the procedures for considering rescissions.