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Compliance In Focus
Posted by John Lehmann on Mon, Aug 6, 2012

Does the US Win Gold in Medical Devices?

US Gold Medical DevicesIt’s the age old debate… Is the US regulatory system or the EU regulatory system better for the medical device industry? Recently in PLoS Medicine Journal the results of a systematic review was published that evaluated the two systems.

Here are the basics of the study:

  • The study was done because of concerns about the safety of new medical devices
  • Researchers systematically reviewed evidence about the performance of medical devices
  • Studies included must have reported empirical data about the characteristics, performance metrics, or effectiveness of device evaluation or post-market oversight in the US or EU
  • Two authors separately extracted data and categorized data based on the aspect of device regulation that was assessed

Recommendations/Findings for the US Regulatory System:

  • Could improve oversight of device approval concerning practices that permit approval of high-risk devices based on limited evidence
  • Concern that many PMA approvals in the US are based on studies with poorly defined end points, or those without blinding or randomization
  • Better post-market surveillance of devices approved based on such limited data is necessary

Recommendations/Findings for the EU Regulatory System:

  • Found almost no data rigorously addressing device regulation in the EU, apart from a few studies evaluating the timing of approval
  • System changes that elucidate the basis for EU device approval are essential for policymakers seeking to identify the ways in which the system is functioning effectively, and to evaluate the ways it can be improved
  • Better transparency among the EU Notified Bodies

Take a look at the publication and the conclusions. What are your thoughts on the two regulatory systems? Do you feel like there is a clear winner? Share your thoughts with us.

Photo Credit: shawncalhoun



Topics: Medical Devices, Gold Medal, US Regulatory System, EU Regulatory System


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