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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