Regulatory Counsel

0910-AI10 201810 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemptions

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.

]]> Substantive, Nonsignificant First Time Published in The Unified Agenda Proposed Rule Stage Undetermined No Deregulatory 21 CFR 814 21 U.S.C. 351 to 353 21 U.S.C. 360 21 U.S.C. 371 to 375 21 U.S.C. 379 21 U.S.C. 381 No NPRM 06/00/2019 No No None No No No Jessica Udechukwu Walker Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-7911 jessica.walkerudechukwu@fda.hhs.gov Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, Building 71, Silver Spring MD 20993