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HHS/FDA RIN: 0910-AI10 Publication ID: Fall 2018 
Title: ●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.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
CFR Citation: 21 CFR 814   
Legal Authority: 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   
Legal Deadline:  None
Action Date FR Cite
NPRM  06/00/2019 
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