Final Rule Applies Device Regulatory Requirements to LDTs; Enforcement Discretion To Be Phased Out

Dennis Tosh
April 29, 2024 at 06:31 PM EST
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The FDA on April 29 issued its long-anticipated final rule amending its regulations to specify that laboratory developed tests (LDTs) are subject to regulation as devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under the final rule, the agency will phase out its multiyear enforcement discretion approach for LDTs so that in vitro diagnostic products (IVD... Read More

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