Ironically, FDA is sometimes wary of issuing guidances out of concern it will appear it is imposing new rules that will stifle innovation, says Ken Skodacek, Policy Analyst, Clinical Trials Program, Center for Devices and Radiological Health (CDRH). Of course, the tension here is that many in industry hold off implementing a new program with confidence out of fear the FDA won’t like its approach, e.g. mHealth and 21 CFR Part 11.

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

Still, the FDA must be doing something right given stats it released last week (September 25). Here are some of the results Skodacek and team are boasting about:

  • Nearly 75% of IDE Studies are now fully approved within two cycles, compared to 63% last year and just under 15% in FY 2011.
  • The median days for full IDE Study Approval has dropped to thirty. That’s down from 101 in FY2014, and way down from the 442 days it took in FY 2011.
  • Teleconference of in-person meetings are now offered to all sponsors of a disapproved IDE within ten days of the decision.
  • Overall, there was a 50% increase in the number of Early Feasibility Study (EFS) submissions for the first nine months of FY 2015 when compared to FY 2013. 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% between FY 2015 and FY 2013.
  • The number of EFS submissions increased in six of seven 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 virtual communications.

About AssurX, Inc.
AssurX, Inc. provides global companies with enterprise quality management systems and regulatory compliance software solutions. AssurX’s flexible, all-in-one system automates quality and compliance related processes so issues can be centrally managed—from detection to corrective action and trend analysis. It helps collect, organize, analyze and share information to better manage risk and improve quality and compliance performance everywhere in the enterprise.

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