Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
FDA issues safety notice on Covidien catheter. Medtronic stent graft selected for FDA’s early feasibility pilot program. More regulatory news.
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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 Finalizes Guidance On Early-Stage Clinical Trials
FDA released final guidance on granting investigational device exemptions for early feasibility medical device clinical studies Oct. 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.
CDRH Sequestration Impact: Training, Standards And Reg Science
CDRH Director Jeffrey Shuren detailed last week how federal sequestration cuts to FDA are impacting specific device center programs, including training, standards development and regulatory science. Shuren also signaled imminent policy releases from the center, including a finalized post-market surveillance plan.