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HHS/FDA RIN: 0910-AI10 Publication ID: Fall 2021 
Title: Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications 

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.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 814   
Legal Authority: 21 U.S.C. 360e    21 U.S.C. 360j(h)    21 U.S.C. 360j(m)    21 U.S.C. 371(a)   
Legal Deadline:  None
Action Date FR Cite
NPRM  12/17/2019  84 FR 68829   
NPRM Comment Period End  03/20/2020 
Final Rule  11/00/2021 
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:
Tami Belouin
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