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

Resumo

The Food and Drug Administration (FDA) is proposing to revise the premarket approval application (PMA) announcement procedure. FDA is proposing to discontinue the publication of PMA approvals and denials in the Federal Register. Instead, the agency is proposing to announce approvals and denials of PMA's on the Internet. Finally, FDA is proposing to make 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.