Earlier this month, FDA's Office of Public Health Strategy and Analysis published a report discussing 20 case studies that purport to support the Agency's push for greater oversight of laboratory developed tests ("LDTs"). LDTs are the subset of in vitro diagnostics ("IVDs") intended for clinical use that are designed, manufactured, and used in a single laboratory. In its report and a related blog post, FDA cites events related to 20 LDTs in which patients had been harmed or may have been harmed by tests that did not meet FDA requirements. The Agency argues the current regulatory framework is inadequate, given the increase in complexity and availability of LDTs.
Historically, FDA has stated it was exercising enforcement discretion in not applying the FDCA to LDTs. Most laboratories making these products are obligated to follow regulatory requirements of the Clinical Laboratory Improvement Amendments ("CLIA"), which are intended to regulate the operations of laboratories but not IVDs specifically. Last year, FDA released two draft guidance documents setting forth FDA's proposed framework for regulating LDTs as medical devices under the FDCA (see the Jones Day Commentary for more details). The recent report advances those efforts by asserting that the CLIA regime does not "ensure the safety and effectiveness of LDTs prior to marketing; assess the quality of the design and manufacture of devices; ensure test labeling provides adequate directions for use; require truth in marketing materials and other labeling; require adverse event reporting; permit removal of unsafe devices from the market; require informed consent for patients participating in clinical studies of LDTs; [or] establish procedures for the conduct of such studies." The report states that enhanced oversight is needed but should be appropriately tailored to avoid duplicating the CLIA regime.
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