FDA Formally Rescinds Laboratory-Developed Tests Final Rule

The U.S. Food and Drug Administration (FDA) formally rescinded its final rule regulating laboratory-developed tests as medical devices, and regulatory review is now pending. Because the FDA did not move to appeal this decision, the rescission is essentially a formality.

The recission comes following the decision filed March 31 in the U.S. District Court in the Eastern District of Texas, which ruled the FDA exceeded its authority and subsequently vacated the final rule. The FDA did not appeal this decision.

Once the Office of Information and Regulatory Affairs completes the regulatory review, a formal notice will be posted to the Federal Register within 60 days.

Sources:

https://www.reginfo.gov/public/do/eoDetails?rrid=1044563

https://documents.cap.org/documents/ldt-courtruling-03-31-2025.pdf

https://www.cap.org/advocacy/latest-news-and-practice-data/august-12-2025#story3