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FDA Finalizes Guidance On Early-Stage Clinical Trials

FDA released final guidance on granting investigational device exemptions for early feasibility medical device clinical studies October 1. It grants manufacturers additional flexibility to change the clinical protocol in early feasibility trials, which are often conducted as the device’s design is still being finalized.

FDA finalized guidance intended to encourage early-stage device clinical testing in the US October 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 in fewer than 10 patients, and typically occur before the device...

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