Two-thirds of small medical device and diagnostic companies go to Europe first to obtain clearance for new products rather than seeking initial market entry in the U.S. because the Food and Drug Administration (FDA) 510(k) process is confusing, according to an industry-wide survey conducted by researchers at Northwestern University.
According to the survey, which was performed between December 2010 and February 2011, both large and small companies reported that unclear guidelines, inconsistent implementation, and lead reviewer turnover contribute to increasing unpredictability of the process. Only 8% of survey respondents said the 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, wrote lead researcher John Linehan, PhD, professor of biomedical engineering at Northwestern.
The survey found the following:
- 76% of respondents found preparation requirements for a 510(k) submission to be uncertain or unclear.
- 72% felt that information requests from FDA reviewers went beyond the requirements established in guidance documents.
- 59% reported no guidance documents existed for their devices.
More than two-thirds of all respondents reported that FDA requests had a significant impact on their financial resources, Linehan wrote.
