According to ACLA, the HHS has let pass its 60-day deadline to lodge notice-of-appeal regarding the FDA LDT Rule. The Notice of Appeal would have kept alive the case which otherwise terminated with the Texas judge's ruling 60 days ago. O quote the ACLA below; see the original link for ongoing community commentary.
https://www.linkedin.com/feed/update/urn:li:activity:7334443741191057408/
See similarly a blog at FDA LAW BLOG:
The ACLA writes,
The U.S. Department of Health and Human Services (HHS) declined to appeal the landmark ruling issued on March 31, 2025 by the U.S. District Court for the Eastern District of Texas that vacated the final rule seeking to regulate laboratory developed tests (LDTs) issued by the FDA, confirming that laboratory developed testing services are not “medical devices” subject to FDA’s regulatory oversight. The FDA had until May 30 to file its appeal.
The Court held that the FDA lacks authority to regulate LDTs. These testing services are not mass-produced devices introduced into interstate commerce, but rather diagnostic services developed and performed by laboratory professionals. Congress has never granted the FDA jurisdiction over such services, which are regulated under the Clinical Laboratory Improvement Act (CLIA) by the Centers for Medicare & Medicaid Services (CMS).
This ruling affirms what ACLA has long maintained: the FDA may not regulate laboratory developed testing services as medical devices. FDA’s rule would have resulted in reduced patient access to innovative tests that improve and save lives. Laboratory testing services provide patients and physicians with vital diagnostic information to inform clinical care, advance precision medicine, contribute to the discovery of novel therapeutics, identify rare diseases, and lead the fight against emerging pathogens.
ACLA members remain committed to the highest standards of quality and to ensuring patients benefit from timely, accurate, and accessible testing. ACLA represents the nation’s leading clinical laboratories, and all ACLA member clinical laboratories are fully accredited by the College of American Pathologists (CAP). We look forward to continued collaboration with policymakers to support patients, innovation, and America’s clinical laboratories.
