FDA plans 'new oversight' for LDTs in lieu of final guidance

FDA plans to outline its view of "an appropriate risk-based approach" to regulating laboratory-developed tests in lieu of issuing final guidance on the matter, spokesperson Tara Goodin told BioCentury. In a statement, the agency said it is "working to develop a new oversight policy" for LDTs, and intends to "work with stakeholders, our new Administration, and Congress to get our approach right."

In 2014 draft guidance, FDA proposed an LDT oversight framework that would phase in regulation over a nine-year period and enforce premarket review requirements based on risks associated with LDTs. According to the draft, CMS, which currently oversees LDT regulation under the Clinical Laboratory Improvement Amendments (CLIA), would continue to oversee laboratory operations (see BioCentury, Aug. 11, 2014)...