Lexology October 3, 2023
The U.S. Food and Drug Administration (FDA or the Agency) recently proposed a new rule that has sparked controversy among clinical laboratories and medical device manufacturers. The current regulatory landscape for laboratory developed tests (LDTs) will completely shift under the proposed rule. FDA has long considered LDTs to be medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). But, for nearly 50 years, the Agency has exercised “enforcement discretion” and not actively regulated most LDTs under FDA’s pre- and post-market medical device regulatory authorities. Instead, developers of LDTs have largely been subject to clinical laboratory regulatory requirements administered by the Centers for Medicare & Medicaid Services (CMS). Citing public health concerns and Congressional inaction in implementing diagnostics...
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