Historically, the U.S. Food and Drug Administration (FDA) has exercised enforcement discretion with respect to most laboratory developed tests (LDTs) and has not required laboratories that furnish LDTs to comply with FDA’s regulatory requirements for medical devices, including registration and listing, pre-market review and post-market controls. In recent years, however, FDA has publicly stated that it intends to regulate LDTs as medical devices, primarily due to concerns that the Clinical Laboratory Improvement Amendments of 1988 and its implementing regulations (CLIA) do not require pre-market review of the clinical claims associated with LDTs.
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) requires the FDA to give two congressional committees (the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor and Pensions) 60 days’ notice of the agency’s intent to issue draft or final guidance on the regulation of LDTs, as well as the anticipated contents of such guidance. Under this requirement, on July 31, 2014, the FDA sent these committees the anticipated details of two draft guidance documents—entitled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs),” respectively—that outline the agency’s proposed regulatory framework for LDTs. In these documents, FDA describes its priorities for enforcing pre- and post-market requirements for LDTs and how it intends to phase in enforcement of regulatory requirements for LDTs.
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