FDA’s Draft Guidance: Phase Out of LDT Enforcement

In an article published on September 17, 2024, in Labcompare, an online guide for laboratory managers and research scientists, AGG Food & Drug attorneys Alan Minsk and Laura Dona discussed the FDA’s announcement to phase out its enforcement discretion approach of laboratory developed tests (“LDTs”).

Alan and Laura provided context for LDTs, which had been under FDA’s enforcement discretion since 1976. While LDTs used to be manufactured in small volumes, they now increasingly rely on high-tech instrumentation and software, and are often connected to IT infrastructure and laboratory information management systems. That’s why, recognizing the need for increased regulation, FDA announced a five-part, four-year phaseout policy of its general enforcement discretion.

Alan and Laura advised firms affected by this change to become familiar with this phaseout policy, even if the compliance dates seem far away.

“Understanding specific changes in regulatory responsibility under the phaseout policy allows firms to set workable timelines for compliance,” Alan and Laura said.

To read the full article, please click here.