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Federal RegisterGuidance and regulationPublished Sep 19, 2025
Regulation Identification Number 0910-AJ05 Medical Devices; Laboratory Developed Tests; Implementation of Vacatur
Updated 4 hours ago ()
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
- CISA 3: Information Systems Acquisition, Development and Implementation
- Source record id
- 2025-18239
- First seen by InfoSec Signals
- Sep 23, 2026
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