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FDA, CMS form Interagency Task Force to Coordinate LDT Regulation

NEW YORK (GenomeWeb) – The US Food and Drug Administration and the Centers for Medicare & Medicaid Services have formed a task force to coordinate the two agencies' oversight of laboratory-developed tests (LDTs).

Jeff Shuren, director of FDA's device division, and CMS Chief Medical Officer Patrick Conway announced the formation of the interagency task force in a blog post last week. The FDA last year issued draft guidelines for regulating LDTs, which traditionally have been overseen by CMS under the Clinical Laboratory Improvement Amendments.

In the draft guidelines, FDA has proposed phasing in regulation of LDTs, starting with the highest-risk tests, so that it may ensure their analytical and clinical validity. CMS, meanwhile, oversees the quality of the lab process, Shuren and Conway noted in the post, not the tests themselves. But since LDTs already have to meet CLIA requirements, "we have heard stakeholder confusion about the roles of the two agencies in ensuring quality and concerns about potentially duplicative efforts," the two agency leaders wrote.

To address these concerns, the newly formed FDA/CMS Task Force on LDT Quality Requirements will identify commonality between FDA's quality system regulation and CLIA requirements; clarify responsibilities for labs that have to meet requirements for both FDA and CMS; and manage resources so labs aren't subject to duplicative regulations.

"The task force is currently exploring areas where collaboration may realize greater oversight efficiency and produce the greatest benefit to patients, providers, and laboratories," Shuren and Conway wrote, noting that the agencies will clarify the differences in CMS and FDA terms so labs "better understand what is expected of them."

The task force will conduct education and outreach programs and host a webinar series on the agencies' coordination efforts. The FDA said it is currently reviewing public input it has received on its draft guidance on LDT regulation. "In response to public comments, FDA may modify the proposed framework when we issue final guidance," Shuren and Conway wrote in the blog post.

Lab industry stakeholders have objected that FDA's draft guidelines are more suited for devices, and don't fit the testing services they provide. Recently, a small group of labs, calling themselves the Diagnostic Test Working Group, floated their own regulatory plan that tried to better address the concerns of labs and diagnostic manufacturers alike. Their framework would create a new category, the in vitro clinical test (IVCT), comprising test kits and platforms, as well as laboratory test protocols. Depending on a lab's or manufacturer's activities, IVCT regulation would be spread over CMS, FDA, and the states.