Mahnu Davar Unpacks FDA LDT Regulation Post-Chevron in MedTech Dive and Inside Health Policy

Life Sciences & Healthcare Regulatory practice co-chair Mahnu Davar was recently quoted in MedTech Dive and Inside Health Policy, where he discussed the potential impact of the U.S. Supreme Court's decision to overturn the Chevron doctrine on challenges to the U.S. Food and Drug Administration's authority, particularly concerning its rule on regulating laboratory-developed tests (LDTs).

Davar informed MedTech Dive that with no current legislation addressing the FDA's oversight of LDTs, Congress could agree that a legislative solution would provide a clearer framework following the overturning of Chevron. "It's the kind of thing where hopefully it would give some impetus to the parties to come together again and try to push for congressional action in this area," he said.

Davar told Inside Health Policy that "one of the points industries I think would make in a Loper Bright-type challenge would be, ‘Congress hasn't given you the ability to regulate the practice of laboratory chemistry — the interpretation and analysis of the inputs and outputs requiring professional judgment from a state/CLIA-licensed professional.’"

Read the MedTech Dive article, "FDA's Lab Developed Test Rule Could Be First Check on Agency's Power Post-Chevron."

Read the Inside Health Policy article, "LDT Case Could Provide First Look At Post-Chevron Arguments On FDA Regs."