Rule
19 Sep 2025
medical devices, labeling, fda, health, laboratory developed tests, regulation
💉FDA Regulation Vacatur and Its Impact on Laboratory Developed Tests
On May 6, 2024, the Food and Drug Administration (FDA, the Agency, or we) issued a final rule amending the definition of "in vitro diagnostic products" in FDA's regulations. On March 31, 2025, a federal district court vacated that rule. This final rule reverts to the text of the regulation as it existed prior to the effective date of the May 2024 final rule.
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