Potential avenue for FDA to exercise control over Laboratory Developed Tests?
The regulatory landscape for Laboratory Developed Tests (LDTs) has experienced a significant shift, with a recent court ruling in Texas vacating the Food and Drug Administration's (FDA) final rule on LDTs. The court determined that the FDA lacked statutory authority to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).
In the aftermath of this decision, the FDA chose not to appeal the court's decision, effectively halting their attempt to bring LDTs under formal FDA oversight for the time being. Consequently, LDTs will continue to be primarily regulated under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, overseen by the Centers for Medicare and Medicaid Services.
Despite this setback, the future of LDT regulation remains uncertain and evolving. Companies involved in LDTs are advised to continue assessing their regulatory exposure and remain prepared for potential future actions from the FDA, such as revised rules or targeted enforcement.
Steven Gonzalez, an attorney with Hyman, Phelps & McNamara, stated that this is not the end of the discussion on how LDTs will fit into the FDA regulatory framework. Gonzalez raised questions about the development of a test in a single location and expressed uncertainty about the definition of a single clinical laboratory. He also pointed out that large corporations with multiple lab locations that perform the same or similar test protocols could be a source of ambiguity.
The FDA's warning letter to DRG Instruments, which occurred before the district court's LDT decision, is not a direct response to the order. The letter focused on evidence of unapproved device violations for an assay labeled for research use only, but intended for clinical diagnostic use instead. This incident could potentially be "conceivably one example" of the FDA using its authority over devices to indirectly regulate LDTs, according to Danzis.
The Association for Molecular Pathology (AMP) favors a tiered, risk-based structure that avoids duplication of activities within federal agencies and proposes updating the CLIA regulations through Congress rather than increasing FDA authority. This approach aims to provide a more streamlined and efficient regulatory environment for LDTs.
In conclusion, the FDA's regulatory efforts on LDTs have been significantly impacted by the court ruling, but the future remains uncertain. Companies and stakeholders in the LDT sector should continue to monitor developments closely and prepare for potential changes in the regulatory landscape.
- The vacating of the FDA's final rule on Laboratory Developed Tests (LDTs) has led to a shift in their regulatory landscape, leaving LDTs primarily regulated under the Clinical Laboratory Improvement Amendments (CLIA) of 1988.
- Companies engaged in LDTs should continue assessing their regulatory exposure and prepare for potential future actions from the FDA.
- Stephen Gonzalez, an attorney, suggested that the future of LDT regulation remains uncertain, with questions about the definition of a single clinical laboratory and the development of a test in a single location.
- The FDA's warning letter to DRG Instruments, focusing on unapproved device violations, could be seen as a potential means of indirectly regulating LDTs.
- The Association for Molecular Pathology (AMP) has proposed a tiered, risk-based structure to avoid duplication of activities within federal agencies and update the CLIA regulations through Congress.
- It's essential for all parties involved in the LDT sector to closely monitor developments and prepare for possible changes in the regulatory landscape.
- The role of Artificial Intelligence (AI), analytics, and medtech in the diagnostics, research, medical-conditions, health-and-wellness, and news sectors within this evolving LDT regulatory landscape is an interesting area for further analysis and discussion.
