Article preview from "The Gray Sheet"- March 12, 2014
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.
CDRH’s Owen Faris: New Clinical Trials Program Will Speed Up IDE Approvals
Article preview from "The Gray Sheet"- March 12, 2014
CDRH established a new clinical trials director position last month to implement policies designed to reduce the time and number of review cycles for investigational device exemptions.
Owen Faris, who assumed the position in an acting capacity on Feb. 9, spoke to “The Gray Sheet” about his vision for the role in a March 12 interview. The device center plans to conduct a national search to permanently fill the position.
The new position was established in conjunction with several CDRH Strategic Priorities
for 2014-2015 that were announced last month to focus on speeding up the IDE review process and encouraging more IDE trials in the U.S. (See "CDRH Focusing On New PMA Pathway, Clinical Trials Program In 2014/2015 Priorities" — "The Gray Sheet," Feb. 5, 2014.) Together, the IDE-focused priorities formerly make up CDRH’s new clinical trials program.
CDRH also recently released an internal standard operating procedure for the review of IDEs. The SOP describes the process for initiating clinical trial director review and collaboration to resolve issues with IDE applications that lead to multiple review cycles.
Faris discussed his ambitious goals for the clinical trial director position, and some concrete steps FDA plans to take to accomplish them. Excerpts from the conversation are below.
Continued...
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