United States: Industry Anticipates Impending FDA Proposed Regulation Addressing Laboratory Developed Tests

Stakeholders prepare for the U.S. Food and Drug Administration's ("FDA") rulemaking effort to "make explicit" that laboratory developed tests ("LDTs") are devices subject to the agency's oversight, reigniting outstanding questions of jurisdiction and authority.

The Office of Management and Budget's Office of Information and Regulatory Affairs ("OIRA") recently received a proposed rulemaking from FDA to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act ("FDCA"). In response, a number of stakeholders from the diagnostics and laboratory industries and research and policy groups have coordinated meetings with multiple agency representatives throughout this month.

FDA, citing its experiences with laboratories during COVID-19 and oncology companion diagnostics, has been signaling its intent to advance administrative action if a legislative solution regarding LDTs was not reached, although it was unclear whether FDA would pursue rulemaking, enforcement, or both. After Congress failed to pass the VALID Act (Verifying Accurate Leading-edge IVCT Development Act) in December 2022, FDA's plan to move forward on at least rulemaking became evident. In June 2023, the Department of Health and Human Services identified a near-term action in the Spring Unified Agenda, proposing a rule to amend regulations to "make explicit" that LDTs are devices under the FDCA.

OIRA has scheduled meetings with several stakeholders, including AdvaMed, the American Clinical Laboratory Association, Association for Molecular Pathology, Center for Science in the Public Interest, Association for Diagnostics and Laboratory Medicine, and Friends of Cancer Research, and agency representatives, reflecting the scope of interest in and potential impact of LDT regulation across U.S. health care-from patients and practitioners to hospital, academic, and clinical laboratories and device manufacturers. But the potential impact extends beyond these meeting participants, including to telehealth services providing or facilitating diagnostic testing as well as public health centers, retailers, and pharmacies offering testing services.

Prior to this development, FDA's last attempt to "clarify" the application of the FDCA and certain implementing regulations to LDTs was through issuance of a 2014 draft guidance, which received strong stakeholder response. Ultimately, FDA abandoned the draft guidance in 2017, instead releasing a discussion paper synthesizing interested party feedback and a possible approach to LDT regulation. Issuance of the proposed rule is anticipated in the coming weeks or months, as FDA previously targeted August 2023 for initiation of the rulemaking.