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HHS/FDA RIN: 0910-AJ05 Publication ID: Spring 2025 
Title: ●Medical Devices; Laboratory Developed Tests; Rescission 
Abstract:

This rule will rescind the amendment to the Food and Drug Administration’s regulations at 21 CFR 809.3(a) that added the words "including when the manufacturer of these products is a laboratory”, reverting to the prior text of the regulation.

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 14192 Designation: Deregulatory 
CFR Citation: 21 CFR 809   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 351    21 U.S.C. 352    21 U.S.C. 360c    5 U.S.C. 801   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Final Rule  09/00/2025 
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:
Eitan Bernstein
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, WO 66,
Silver Spring, MD 20993
Phone:240 402-9812
Email: eitan.bernstein@fda.hhs.gov