FDA Finalizes Guidance On Early-Stage Clinical Trials

FDA finalized guidance intended to encourage early-stage device clinical testing in the U.S. Oct. 1. The final guidance, which closely tracks a draft version from 2011, attempts to streamline the pathway for gaining investigational device exemptions for early feasibility trials including some first-in-human device studies.

Early feasibility studies test a device’s safety and functionality on less than 10 patients, and typically occur before the device design is finalized. Due to strict regulatory requirements, the vast...