FDA Finalizes Guidance On Early-Stage Clinical Trials
Executive Summary
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.
You may also be interested in...
Regulatory News In Brief
FDA issues safety notice on Covidien catheter. Medtronic stent graft selected for FDA’s early feasibility pilot program. More regulatory news.
Regulatory News In Brief
Industry responds favorably to FDA's early-feasibility-study draft guidance. Circulatory System Devices panel to vote on HeartWare and Cameron Health devices. More regulatory news.
Jumpstarting U.S. Device Trials? FDA Makes Effort In New Draft Guidelines
New FDA guidances aim to strike a balance by allowing firms to begin trials earlier through adaptive study designs, while ensuring that patients are adequately protected.