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HHS/FDA RIN: 0910-AI85 Publication ID: Spring 2024 
Title: Medical Devices; Laboratory Developed Tests 
Abstract:

This rule would amend the Food and Drug Administration’s regulations to make explicit that laboratory developed tests (LDTs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act.)

 
Agency: Department of Health and Human Services(HHS)  Priority: Section 3(f)(1) Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: Yes  Unfunded Mandates: Private Sector 
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    ...   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  10/03/2023  88 FR 68006   
NPRM Comment Period End  12/04/2023 
Final Rule  05/06/2024  89 FR 37286   
Final Rule Effective  07/05/2024 
Regulatory Flexibility Analysis Required: YES  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: Yes 
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