Regulatory Counsel

0910-AI85 202404 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Medical Devices; Laboratory Developed Tests

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.)

]]> Section 3(f)(1) Significant Previously Published in The Unified Agenda Completed Actions Yes Private Sector 21 CFR 809 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 ... Yes 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 YES Businesses None No Yes No Eitan Bernstein Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-9812 eitan.bernstein@fda.hhs.gov 10903 New Hampshire Avenue, WO 66, Silver Spring MD 20993