Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Industry responds favorably to FDA's early-feasibility-study draft guidance.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.
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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 Officials Talk New Guidance, Post-Market Surveillance And 510(k)s At AdvaMed
CDRH Director Jeffrey Shuren told participants at the AdvaMed annual meeting to expect early feasibility studies final guidance very soon and a guidance on 3D printing within two years. The center also announced updates on its national post-market surveillance plan and 510(k) refuse-to-accept policy programs, among other matters.