Legislation Would Restrict Regulation of LDT Procedures to CMS, Prohibit Any Oversight by FDA
June 16, 2021 at 11:46 PM EST
A bill reintroduced by Sen. Rand Paul, R-Ky., would ensure that “all aspects” of laboratory-developed test (LDT) procedures are regulated solely by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA), 42 U.S.C. §263a, and would block the procedures from being regulated by the FDA under the Federal Food, Drug, and Cos... Read More
