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.

Tags

information blocking, Rule, Health and Human Services Department, Food and Drug Administration

Related exam domains

None matched

Source record id

2025-18239

First seen by InfoSec Signals

9/23/2026

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