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 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.
Jeni Clark, BSME, the associate director of UTEP’s CREIE (Center for Research, Entrepreneurship and Innovative Enterprises), said these survey findings are timely, as the FDA's Center for Devices and Radiological Health (CDRH) is weighing regulatory revisions that support innovation; bring important, safe, and effective technologies to patients quickly; and keep jobs in the United States. The agency has also commissioned the Institute of Medicine (IOM) to produce an independent review panel report, which is expected to be released this summer.
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