On Friday or Saturday - depending on who your read - the FDA did not file an appeal to challenge to the Texas District Court decision to vacate the LDT Final Rule. That means the Final Rule is dead as written. Lots of articles out there on the topic - here are just three:
https://www.ascp.org/news/news-details/2025/06/02/the-ldt-final-rule-is-officially-dead--fda-has-no-jurisdiction
https://www.medtechdive.com/news/FDA-declines-appeal-lab-developed-tests-LDTs-ruling/749667/
https://news.bloomberglaw.com/health-law-and-business/fda-skips-move-to-revive-suit-over-agencys-lab-test-authority
#fda #LDT #FinalRuleVacated
------------------------------
Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
------------------------------
</bioanalysisandbiomarkers.blogspot.com>