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

rn, they aimed to provide insight into how U.S. companies are navigating the changing regulatory environment at home. Among key findings of the survey:

Respondents find the consistency and efficiency of FDA's review process a concern.

  • Three-quarters of respondents (76%) 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; and 59% reported no guidance documents existed for their devices.
  • During the past three years, respondents experienced changes in the lead FDA reviewer for approximately 14% of their submissions; of those, 60% felt the change negatively affected the product review.
  • More than two-thirds of all respondents reported that FDA requests had a significant impact on their financial resources.

  • Small companies are more likely to incur expensive and time-consuming difficulties in navigating the process.

  • The development process for small companies -- which are involved with new products twice as often as large companies -- is significantly longer than for large companies (26.6 months versus 17.7 months).
  • Small company respondents report an average total review time of 330 days, while those in large companies report 177 days.

  • Seeking regulatory clearance and market launch outside the U.S. is becoming increasingly common.

  • Only 4% of respondents reported approaching FDA as the first regulator to discuss and plan their submission for a new device, while 80% initially approached EU regulatory bodies.
  • In the device-specific portion of the survey, respondents said that 65% of devices were CE-marked before receiving FDA clearance.
  • Data suggest that current U.S. review time is more than twice as long as in the EU (part of it attributable to differences in regulatory requirements between the U.S. and the EU).

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    SOURCE The Institute for Health Technology Studies (InHealth)
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