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Michael Causey

FDA Compliance

FDA Touts Improved IDE Review Stats

Nearly 75 percent of Investigational Device Exemption studies are fully approved within two cycles

Published: Wednesday, October 7, 2015 - 15:26

Ironically, the U.S. Food and Drug Administration (FDA) is sometimes wary of issuing guidances out of concern it will appear to be imposing new rules that will stifle innovation, according to Ken Skodacek, a policy analyst for the Clinical Trials Program at the Center for Devices and Radiological Health (CDRH). Of course, the tension here is that many in industry hold off implementing a new program out of fear the FDA won’t like its approach, e.g., mobile health and 21 CFR Part 11.

The agency is trying, with renewed vigor, to find that balance between giving industry direction without making it feel handcuffed.

Still, the FDA must be doing something right, given the stats it released Sept. 25, 2015. Here are some of the results Skodacek and team are boasting about:
• Nearly 75 percent of Investigational Device Exemption (IDE) studies are now fully approved within two cycles, compared to 63 percent last year and just under 15 percent in FY2011.
• The median days for full IDE study approval has dropped to 30. That’s down from 101 in FY2014, and way down from the 442 days it took in FY2011.
• Teleconferences of in-person meetings are now offered to all sponsors of a disapproved IDE within 10 days of the decision.
• Overall, there was a 50-percent increase in the number of Early Feasibility Study (EFS) submissions for the first nine months of FY2015 when compared to FY2013. Skodacek urged device makers to take advantage of this offering and noted there are no costs or user fees association with it.
• EFS approval rates jumped up 100 percent between FY2015 and FY2013.
• The number of EFS submissions increased in six of seven Office of Device Evaluation (ODE) review divisions during the same time period.

Skodacek noted that the FDA is genuinely working to change its review approach and genuinely wants to be an inspiration, not a roadblock, when it comes to innovation. For example, CDRH notes in a new blog post that it has trained review staff to give them a better understanding of the challenges of conducting a successful device trial. More than 100 reviewers have gone on site to visit trial sponsors.

Skodacek said he couldn’t emphasize enough the value of in-person, or teleconference communications. Emails and snail mail are fine ways to share some information, but the most effective way to best understand FDA expectations, and to help them understand your rationale, is face to face, whether it’s live eyeball to eyeball, or via virtual communications.

First published Sept. 29, 2015, on the AssurXblog.


About The Author

Michael Causey’s picture

Michael Causey

James Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past 10+ years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers. Causey is the editor and publisher of eDataIntegrityReport.com and is a contributing writer on the AssurXblog.