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HHS/FDA | RIN: 0910-AI10 | Publication ID: Fall 2020 |
Title: Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications | |
Abstract:
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. |
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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 |
EO 13771 Designation: Deregulatory | |
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 |
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Timetable:
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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 Email: jessica.walkerudechukwu@fda.hhs.gov |