U.S. FDA Targets IVDs, Radiology Devices for Fast-Track Pilot Program

Sponsors of some 510(k)s for in vitro diagnostics and radiological devices could hear back from the U.S. Food and Drug Administration (FDA) more quickly under a pilot program aimed at speeding high-quality applications. The program, managed by the Office of In Vitro Diagnostics (OIVD), was launched April 2 and will last until Oct. 2.
International Medical Device Regulatory Monitor