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FDA is amending its medical device regulations regarding the procedures for the announcement of approvals and denials of premarket approval applications (PMAs) and humanitarian device exemption applications (HDEs). When this rule is finalized, FDA will discontinue publishing in the Federal Register after each quarter a list of PMA and HDE approvals and denials announced that quarter. FDA will continue to post approval and denial notices for PMAs and HDEs on FDA’s home page on the Internet and will also continue to make available on the Internet and place on public display summaries of safety and effectiveness data (SSED) for PMAs and summaries of safety and probable benefit (SSPB) for HDEs. FDA will also continue to make copies of the current PMA approvals and denials document and copies of SSED available, upon written request, through FDA’s Freedom of Information Staff. FDA is taking this action to improve the efficiency of announcing approvals and denials of PMAs and HDEs and to eliminate duplication in the current process of announcing the information.