On 31 March 2025 the US District Court for the Eastern District of Texas vacated FDA's May 2024 final rule on laboratory developed tests, holding that FDA lacked authority to regulate LDTs as devices under the FD&C Act. FDA did not appeal, and the phased compliance timeline we described in 2024 no longer applies.
What still applies
CLIA requirements for laboratory quality and personnel remain in force, as do state laboratory laws, and FDA continues to regulate test kits and components sold to laboratories. Laboratories offering tests in markets that require regulatory approval, including the EU under the IVDR, are unaffected by the US ruling.
Our advice
- Keep the LDT inventory and risk classification; they are useful for CLIA inspections and for any future rule.
- Keep complaint handling and corrections/removals procedures that were built for Stage 1; they are good practice and cost little.
- Pause premarket submission preparation unless the test is also headed for a market that needs it.
Vakula's regulatory affairs consultants can help laboratories decide what to retain.