FDA, CMS create LDT task force

In response to stakeholder concerns regarding FDA's proposed plan for regulating laboratory-developed tests (LDTs), FDA and CMS are establishing a joint task force dedicated to LDT oversight. The group will identify redundancies between the regulatory roles of FDA and CMS and clarify requirements for laboratories that will undergo review by both agencies.

FDA released two draft guidance documents in October outlining the agency's plans for LDT oversight. Under the proposed framework, FDA would enforce requirements for establishing a test's analytical validity and clinical validity. CMS would continue to oversee laboratory operations through the Clinical Laboratory Improvement Amendments (CLIA). LDTs have been regulated by CMS under CLIA since 1988, but CLIA does not require premarket review of tests or evidence of clinical validity (see BioCentury, Aug. 11, 2014). ...