Thursday, April 5, 2012

GAO Says Device Reviews Are Taking Longer…and FDA Says It Is Because Your Submission had Quality Issues

In a report released last week, the U.S. Government Accountability Office (“GAO”) provides the results from a study it conducted to determine whether FDA has met timeframe performance goals related to the completion of reviews for premarket notification (510(k)) submissions and premarket approval (“PMA”) applications.

The study found that while FDA met performance goals for 510(k)s and the average number of submissions per year remained generally steady during fiscal year (“FY”) 2003 through FY 2010, the review times for 510(k)s increased.  Likewise, review times for PMAs also increased despite FDA meeting most performance goals for PMA applications.  There has also been a decrease in the number of 510(k) clearance determinations and PMA approvals.  In sum, FDA is taking longer to complete the reviews of 510(k)s and PMAs when the purpose of the user fee program was to streamline the regulatory process.

And who is responsible for this unintended effect?  While assuming some responsibility, FDA points a heavy finger at industry stakeholders.  We will explain this further below, after first providing a brief overview of the device user fee program and discussing the noteworthy GAO study results.

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/04/gao-says-device-reviews-are-taking-longerand-fda-says-it-is-because-your-submission-had-quality-issu.html

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