New FDA Device Rule No Cure For Unregulated Lab Tests

New FDA Device Rule No Cure For Unregulated Lab Tests

May 7, 2024, Law360

Scott Danzis’ commentary was included in a Law360 article covering the Food and Drug Administration’s (FDA) new rule attempting to regulate laboratory-developed tests (LDTs). Scott discusses how the new regulatory framework established by the FDA will allow tests currently marketed under the LDT regulatory pathway to remain on the market without undergoing premarket review.

“It's not possible to say how many, but some say upwards of 100,000 tests will remain on the market without FDA premarket review, and they can stay in the market unless they're significantly modified,” Scott said.