FDA’s Latest Salvo in the LDT (Laboratory Developed Tests) Wars

Please join members of King & Spalding’s FDA and Life Sciences team, who will provide an overview of FDA’s proposed rule on laboratory developed tests.

On September 29, 2023, FDA published the long awaited proposed rule on laboratory developed tests (“LDT Proposed Rule”). The proposed rule was FDA’s latest salvo in the LDT war. Rumors suggest that FDA plans to finalize the proposed rule in April, and if that is the case, it will be an enormous jurisdictional expansion – FDA’s budget will have to increase by approximately 50%. Find out what you need to know to be prepared.