FDA Releases Laboratory-Developed Tests Final Rule

The landscape of laboratory testing in the United States is changing.

On April 29, 2024, following more than a decade of discourse, the U.S. Food and Drug Administration (FDA, or the “Agency”) released its long-awaited “Medical Devices; Laboratory Developed Tests” final rule (the “Final Rule”) formalizing the Agency’s authority to regulate laboratory-developed tests (LDTs) as medical devices.

Since the FDA issued its proposed rule (the “Proposed Rule”) in the fall of 2023, Epstein Becker Green and other industry stakeholders have eagerly awaited the Agency’s issuance of the Final Rule and have speculated as to the provisions of the Proposed Rule that the Agency would choose to finalize.

For now, here are important preliminary takeaways from the Final Rule:

• The FDA intends to exercise different levels of enforcement discretion for certain categories of LDTs.
• The Agency finalized a four-year phase-out structure for implementing the Final Rule.
• Opponents of the Final Rule project increased costs to laboratories of between $2.39 billion and $19.45 billion annually.
• Because the FDA issued the Final Rule before May, a rollback would likely not be possible, even if a new administration takes office after the upcoming presidential election.

What does all of this mean for you?

• Stakeholders should be on the lookout for legal challenges to the Final Rule and lobbying efforts to affect its implementation.

For more information on the Final Rule, see "It’s Been a Long Time Coming – FDA’s Final Rule on Regulation of Laboratory Developed Tests (LDTs) as Medical Devices Has Arrived."