The Pre-Decisional IDE: FDA’s New Proposal To Help Studies Get Started Right
This article was originally published in The Gray Sheet
Executive Summary
FDA detailed its proposal for a new “pre-decisional IDE review process” in a revised draft guidance issued June 14. The voluntary process would occur prior to IDE submission and would offer companies comprehensive feedback on where their study plans fall short in gaining IDE approval and in ultimately gaining marketing approval.
You may also be interested in...
FDA Abandons Proposal For Interactive, “Pre-Decisional” IDE
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.
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.
FDA Articulates Design Principles For Pivotal Trials In Final Guidance
The agency prefers device pivotal trials to be randomized, double-blinded and controlled, but understands that this is “neither feasible nor practical” for some devices, according to a Nov. 7 final guidance.