FDA seeks 'complementary approach' to regulating LDTs

In a discussion paper addressing regulation of laboratory-developed tests, FDA said it is continuing to evaluate comments and proposals from stakeholders to determine an appropriate way to regulate laboratory-developed tests, and is seeking a "complementary approach" that would garner support from the broadest array of stakeholders. The agency said a prospective oversight framework focused on new and higher risk LDTs would best serve public health while advancing laboratory medicine.

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