Regulatory Focus™ > News Articles > Study: Who Regulates Medical Devices Better: US or EU?

Study: Who Regulates Medical Devices Better: US or EU?

Posted 01 August 2012 | By Alexander Gaffney, RAC 

How do the US and EU regulatory systems for medical devices match up in a head-to-head comparison? A new systematic review published in the journal Public Library of Science: Medicine (PLoS:M) says there's no clear winner, and each regulatory system is rife with both faults and opportunities to reform.

The paper, How Does Medical Device Regulation perform in the United States and the European Union? A systematic Review, looked at a total of 21 studies assessing either the pre-market evaluation and timing capacities of the systems, the number and timing of device recalls  or the perceptions of device manufacturers.

Authors Daniel Kramer, Shuai Xu and Aaron Kesselheim said their findings presented "few reasonably firm conclusions." Limited data, statistically insignificant sub-samples and inconsistent approaches hamstrung their ability to make apples-to-apples comparisons, they said, and a relative lack of studies on the subject further complicated matters.

US Reform Recommendations

"In general … the outcomes addressed by the studies in our review limit the ability to draw conclusions from them," the authors wrote, though they noted several areas were particularly ripe for reform.

"The FDA, which is the subject of all but one (19/20, 95%) of the studies and reports in our sample, could improve oversight of device approval in important ways," the authors noted, pointing to the agency's approval of some higher-risk devices with limited approval data. Still other studies used to support approval used "poorly defined endpoints" or did not use blinding or randomization techniques-features "assumed to be consistent with high-quality clinical trials."

The authors said this was problematic, as 78% of all medical devices recalled by the agency were not initially identified as being "high risk" devices. "These data are concerning because they indicate that devices not considered high risk at the time of regulatory evaluation can often subsequently present serious dangers to patients," the authors wrote in an accompanying editorial.

The authors recommended boosting FDA's funding to allow for more staff to conduct robust and timely reviews, as well as the ability to fund the development of new regulatory science technologies to allow for speedier reviews.

EU Reform Recommendations

Data problems were even more pronounced in the EU, and the authors noted data transparency issues among EU notified bodies, "Which generally do not release the data upon which they make their approval determinations."

The authors said the lack of data available to researchers was preventing the types of in-depth analysis its US counterpart is regularly subject to, and that this area was in need of reform.

"Thus," said the authors, "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."

The authors said they hoped their analysis and recommendations would, "Provide some insights for policymakers seeking to reform device regulation in the US and EU, including the need for greater transparency and coordinated oversight in the EU."

"It remains unclear whether the US or EU approach achieves better outcomes for patients receiving devices," they concluded.

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