Data / Federal rules / 2025-18239
Regulation Identification Number 0910-AJ05 Medical Devices; Laboratory Developed Tests; Implementation of Vacatur
The Food and Drug Administration published this final rule in the Federal Register on September 19, 2025. It took effect on September 19, 2025.
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What the agency says
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.
Key facts
- Document number
- 2025-18239
- Type
- Final rule
- Action
- Final rule
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- September 19, 2025
- Takes effect
- September 19, 2025
- Dates
- This rule is effective September 19, 2025.
- Docket
- Docket No. FDA-2025-N-1730
- Code of Federal Regulations
- 21 CFR 809
- Topics
- Labeling; Medical devices
- Pages
- 3
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on labeling · Rules on medical devices · Published in September 2025
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.