Study: Device Recalls In Europe, U.S. Occur At Similar Rates No Safety Benefit from Slower, More Burdensome FDA Process

WASHINGTON, D.C. – A report released today by the Advanced Medical Technology Association (AdvaMed) shows medical device recalls in Europe and the U.S. occur at about the same rate, even though the approval process in the U.S. takes significantly longer.

“It’s well-documented that it takes longer to bring medical technology to market in the U.S. than it does in Europe. Today’s report suggests that the delay denies patients access to the most up-to-date treatments and cures without a corresponding increase in safety,” said Stephen J. Ubl, AdvaMed President and CEO.

The report examines the rate of safety recalls for medical devices in Europe from 2005-2009 and compares them with the level of similar recalls in the U.S. The study focused on those products recalled because of significant health risks and found an average recall rate in Europe of 21 per year, compared to the tens of thousands of devices on the market. This is almost identical to the rate of equivalent recalls in the U.S.

“The results of this study suggest little difference between absolute number of serious recalls between the U.S. and EU regulatory systems,” the report says. “The distribution of the serious recalls is similar across therapeutic areas and reasons for recall, suggesting that differences between the two systems do not ultimately affect performance.”

FDA data shows the time it takes to review and approve a product in the U.S. has increased substantially in recent years. Today’s report comes out less than two weeks after a Medical Technology Innovation Scorecard by PwC showed regulatory approval times in the U.S. now rank close to the bottom – seventh out of the nine competitor nations that PwC studied. And a recent study by Stanford professor Dr. Josh Makower reported that on average FDA reviews for 510(k) products take two years longer from the point of initial communication with the regulatory agency than reviews for similar products in Europe. For PMA devices, the gap climbs to more than three and a half years.

“The FDA should focus on resolving key performance issues to provide patients timely access to life-saving and life-changing medical technology and improve American competitiveness,” Ubl said. “We believe the FDA is beginning to recognize these problems and that U.S. policymakers in both parties want to reverse these recent trends. Medical technology companies are committed to working with the FDA to improve the efficiency of the review process while continuing to assure that products are safe and effective.”

The AdvaMed-sponsored report was prepared by Scott Davis, Erik Gilbertson and Simon Goodall of The Boston Consulting Group, a global business management consulting firm.

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