The Boys Are Back in Town: FDA’s Draft Guidance for Compliance With the Phase-Out of LDT Enforcement Discretion

Thin Lizzy famously declared in their 1976 hit, “The Boys are Back in Town.” The same is true almost 50 years later, as the U.S. Food and Drug Administration has announced its plan to phase out its general enforcement discretion approach of laboratory developed tests (“LDTs”) and bring the boys back for enforcement. On May 6, 2024, FDA published its Final Rule, clarifying that in vitro diagnostic products (“IVDs”) are medical devices under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”),…
By: Arnall Golden Gregory LLP