Early indications suggest that a new body lower court–and likely Supreme Court–precedent regarding agency deference will quickly develop in the wake of the Supreme Court’s Loper Bright Enterprises v. Raimondo decision. For example, MedTech Dive points out:
Critics of the Food and Drug Administration’s new lab developed test (LDT) regulation have accused the agency of overstepping its statutory authority in defining LDTs as medical devices. Less than a month after the final rule was issued, the American Clinical Laboratory Association (ACLA) sued the FDA in the U.S. District Court for the Eastern District of Texas (Case No. 4:24-cv-00479-SDJ) to have the rule vacated. Congress never granted the FDA the authority to regulate the provision of testing services by clinical laboratories, argued the ACLA, whose members include Labcorp, Quest Diagnostics and other test developers.
The Supreme Court’s decisions in Loper and Relentless overturning the Chevron deference standard will now shape the court’s review of the ACLA’s challenge, legal experts said.