Revising the Announcement Procedures for Approvals and Denials of Premarket Approval Applications

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The Food and Drug Administration (FDA) is issuing a final rule to revise the premarket approval application (PMA) announcement procedure. FDA is discontinuing the publication of individual PMA approvals and denials in the Federal Register. Instead, the agency will announce approvals and denials of PMA's on the Internet. FDA will make the summaries of safety and effectiveness available through the Internet and by placing them in FDA's Dockets Management Branch. FDA will publish in the Federal Register for each quarter a list of the approvals and denials announced in that quarter. FDA is taking this action in order to expedite the availability of this information.