AHA: FDA should not regulate Laboratory Developed Tests as medical devices

The Food and Drug Administration should not apply medical device regulations to Laboratory Developed Tests, AHA told the agency today. FDA’s draft framework for regulatory oversight of LDTs and related guidance, “while well-intentioned, is inappropriate and will lead to a loss of patient access to many critical tests,” wrote AHA Executive Vice President Rick Pollack. Instead of subjecting clinical laboratories to multiple oversight agencies, he said “a better approach” would be to modernize and enhance the Clinical Laboratory Improvement Amendments. The letter urges the Centers for Medicare & Medicaid Services, Centers for Disease Control and Prevention and FDA “to engage stakeholders in a transparent process and propose a new framework, through notice-and-comment rulemaking, that identifies gaps in oversight and how agencies could fill those gaps while avoiding contradictory and ambiguous regulations.” LDTs are not commercially distributed but are developed, validated and performed in-house by individual laboratories, including hospital laboratories, when commercial diagnostic tests do not exist or meet clinical needs.