Questions Linger After FDA's Lab-Developed Tests Proposal

By Scott Danzis, Amy Leiser and Wade Ackerman · October 20, 2023, 5:33 PM EDT

On Sept. 29, and as widely anticipated, the U.S. Food and Drug Administration announced the publication of a proposed rule to clarify that lab-developed tests, or LDTs, are medical devices subject...

To view the full article, register now.