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FDA is proposing to amend 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). FDA is proposing to discontinue publishing in the Federal Register after each quarter a list of PMA and HDE approvals announced that quarter.  FDA would continue to make copies of the current PMA and HDE approvals and denials documents, copies of summaries of safety and effectiveness for PMAs, and copies of summaries of safety probable benefit for HDEs available through the Division of Dockets Management. In addition, FDA would continue to post this information on FDA’s web page on the Internet. 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.