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FDA Abandons Proposal For Interactive, “Pre-Decisional” IDE

This article was originally published in The Gray Sheet

Executive Summary

The agency finalized a guidance document on investigational device exemption review decisions, dropping a proposal to establish a new, interactive “pre-decisional” IDE process. Industry had been skeptical that the proposed program would improve efficiency of study reviews, and worries that it would require a lot of FDA resources.

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FDA Updates Its Criteria For Medicare Coverage Of Device Trials

The agency has long been partnering with CMS to set coverage for investigational device exemption studies by designating IDE trials as "category A" or "category B." A new FDA draft guidance and memorandum of understanding between FDA and CMS are intended to modernize the criteria for those trial categories.

CDRH’s Owen Faris: New Clinical Trials Program Will Speed Up IDE Approvals

In an interview with “The Gray Sheet,” CDRH’s Acting Clinical Trials Director Owen Faris discusses the device center’s new pre-market clinical trials program aimed at speeding up approval times for investigational device exemptions and increasing the number of IDE trials in the U.S.

Industry Asks FDA To Relay Study Design Concerns Separately From IDE Decisions

In comments on FDA’s draft investigational device exemption guidance, device manufacturers ask the agency to communicate any study design considerations or future considerations for IDE studies in communications separate from the official IDE decision letter.

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