Final rule · 2025-18239

Regulation Identification Number 0910-AJ05 Medical Devices; Laboratory Developed Tests; Implementation of Vacatur

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.