FDA challenges medical device approval comparisons with Europe

By Julian Pecquet - 02/17/11 01:46 PM ET

The Food and Drug Administration defended its approval process for medical devices during a congressional hearing Thursday and said industry comparisons with Europe are off the mark.

Device makers argue that the United States is losing its global competitive edge, in part because the federal approval process is both less predictable and slower than in other countries — about two years slower than in Europe for low- and moderate-risk devices and even longer for riskier devices.

The FDA's director of devices and radiological health testified before the Energy and Commerce health subcommittee that a recent study overestimated the FDA's review time because it included "the substantial pre-submission assistance to the industry that FDA offers."

"Some would say that, despite the record of growth and prosperity in the U.S. device industry, the European regulatory system is better for industry and patients," Jeffrey Shuren said. "It is difficult to make direct comparisons between the U.S. and European systems given their fundamental differences, including, at the most basic level, differing approval standards — the EU lacks the requirement in U.S. law that a device be shown to be effective."

FDA is under considerable pressure from industry and its allies on Capitol Hill to streamline its so-called "510(k)" expedited approval process for low-risk devices. Device makers say the process is too slow and unpredictable, while some patient advocates believe it's used for far too many approvals.

A new study in the Archives of Internal Medicine found that, of 113 recalls that the FDA determined could cause serious health problems or death between 2005 and 2009, 71 percent were approved through the 510(k) process.

"These findings suggest that reform of the regulatory process is needed to ensure the safety of medical devices," the study authors wrote.

However, other experts said far more devices were approved through the 510(k) process than through other processes, and the recalls amounted to less than 0.5 percent of 510(k) approvals.

"Our study shows that FDA has a very positive safety record in its 510(k) clearance decisions," testified Ralph Hall of the University of Minnesota Law School.

Shuren testified that the agency's review process could be hindered by cuts proposed by House Republicans in their stop-gap budget bill for the rest of the year. The continuing resolution would cut the FDA budget by $220 million.