FDA's Gutierrez clarifies LDT review timelines

FDA's Alberto Gutierrez clarified the agency's timelines as it institutes a regulatory approach for laboratory-developed tests. Gutierrez shared with BioCentury his recent presentation at the Clinical Laboratory Improvement Advisory Committee (CLIAC) meeting in Atlanta and discussed details of the agency's approach, outlined in draft guidance released in September (see BioCentury Extra, Sept. 30).

Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health (OIR) at FDA's Center for Devices and Radiological Health (CDRH), clarified in his presentation that new LDTs in the highest-risk category will be required to undergo premarket review as soon as the agency's final guidance takes effect. Manufacturers of already-marketed LDTs in the highest-risk category will have six months to notify the agency and begin adverse event reporting, and 12 months to submit applications for review. ...