View Rule
View EO 12866 Meetings | Printer-Friendly Version Download RIN Data in XML |
HHS/FDA | RIN: 0910-AI20 | Publication ID: Spring 2024 |
Title: Clinical Holds in Medical Device Investigations | |
Abstract:
The proposed rule would create procedures for suspending, i.e., imposing a hold (a "clinical hold") on, a clinical investigation of a medical device. The proposed rule would implement section 520(g)(8) of the Federal Food, Drug, and Cosmetic Act authorizing clinical holds for device investigations. |
|
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 812 | |
Legal Authority: 21 U.S.C. 360j(g)(8) 21 U.S.C. 371(a) |
Legal Deadline:
None |
||||||
Timetable:
|
Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: John Maiers Regulatory Policy Analyst Department of Health and Human Services Food and Drug Administration 10903 New Hampshire Avenue, Building 66, Room 5500, Center for Devices and Radiological Health, Silver Spring, MD 20993 Phone:301 796-0343 Email: john.maiers@fda.hhs.gov |