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Northwestern Survey Finds FDA Predictability a Top Concern Among Medtech Firms; Europe Preferred for Product Approval
Date:5/24/2011

estigator Jan B. Pietzsch, PhD, president and CEO of the technology consultancy Wing Tech Inc., and a consulting associate professor in Stanford University's Biodesign program and department of management science and engineering, emphasized that the survey offers both industry and FDA opportunities to improve the 510(k) pathway, and that collaboration is needed to secure the future of medical innovation in the United States and patient access to the safest and most-effective medical devices in the world. Among opportunities identified in the survey:

  • Respondents stated that their companies could have improved the initial submission for 39% of applications submitted in the past three years.
  • On average, respondents felt that 26% of FDA's follow-up questions should have been anticipated.

  • "The responses indicate that there may be opportunities for industry to better anticipate FDA's evidentiary needs during the regulatory process, as long as they are clearly stated and communicated," said Pietzsch. "Similarly, the process would benefit from FDA better training inexperienced reviewers on how to treat submissions consistently." He added that 92% of respondents perceived a correlation between inexperienced reviewers and more FDA questions.

    The survey findings are timely, as 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. (See sidebar on how the Northwestern survey responses align with the CDRH's action plan of January 2011.) 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.

    Interviews with more than 80 medtech experts from FDA and industry informed the survey's content. For the s
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    SOURCE The Institute for Health Technology Studies (InHealth)
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