WASHINGTON, May 24, 2011 /PRNewswire/ — Two-thirds of small
medical device and diagnostic companies — the drivers of
innovation in the sector — are obtaining clearance for new
products in Europe first, suggesting delayed market entry in the
U.S., according to a comprehensive industry-wide survey about FDA’s
510(k) product review process by researchers at Northwestern
University.
Large and small companies reported that unclear guidelines,
inconsistent implementation, and lead reviewer turnover are
contributing to increasing unpredictability of the process. Only 8%
of survey respondents believe FDA’s 510(k) product review process
is the most predictable regulatory system, as compared with roughly
two-thirds of respondents who stated that Europe’s CE marking
process is the most predictable.
For 98% of those surveyed, the predictability of regulatory
requirements is a crucial factor in deciding whether to invest in
developing a new product. According to lead researcher John
Linehan, PhD, professor of biomedical engineering at Northwestern
University, the U.S. regulatory system has been widely credited
with ensuring high standards of patient safety and device
effectiveness, while also facilitating innovation. But increasing
uncertainty about the implementation of the 510(k) process —
partly attributable to increases in device complexity — is posing
challenges for FDA and industry that may lead the United States to
experience a “brain drain” in the medtech sector.
“As FDA considers regulatory revisions, what’s at stake is the
ability of companies to attract investors in order to continue
developing innovative, life-saving products and sustaining American
competitiveness in the global marketplace,” Linehan said.
Through an online survey of more than 350 professionals engaged
in medical device development, researchers sought to determine what
works well in the 510(k) process and how its implementation can be
further strengthened. In tu
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