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HHS/FDA RIN: 0910-AI10 Publication ID: Fall 2019 
Title: Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications 

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 and denials announced that quarter. FDA would continue to post approval and denial notices for PMAs and HDEs on FDA’s home page on the Internet and would 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 would 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 proposing to take 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.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
CFR Citation: 21 CFR 814   
Legal Authority: 21 U.S.C. 360e    21 U.S.C. 360i(h)    21 U.S.C. 360i(m)    21 U.S.C. 371(a)   
Legal Deadline:  None
Action Date FR Cite
NPRM  11/00/2019 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Jessica Walker Udechukwu
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, Building 71,
Silver Spring, MD 20993
Phone:240 402-7911