Non-binding Guidance: FDA’s Proposed Rule on Laboratory Developed Tests

Lexology October 30, 2023
Ropes & Gray LLP

This installment of Ropes & Gray’s podcast series Non-binding Guidance focuses on FDA’s proposed rule that would affirm the Agency’s position that laboratory developed tests (“LDTs”) are in vitro diagnostic products regulated as medical devices under the Federal Food, Drug, and Cosmetic Act (“FDCA”). In this episode, hear from Greg Levine, Josh Oyster, and Beth Weinman, industry-leading attorneys from Ropes & Gray’s life sciences regulatory and compliance team based in Washington, D.C., as they discuss FDA’s proposal to phase out the enforcement discretion policy it has historically applied to most LDTs.

Non-binding Guidance Episode 25

FDA’s Proposed Rule on Laboratory Developed Tests

Transcript:

Greg Levine: Hi, I’m Greg Levine, head of the life...