FDA challenges medical device approval comparisons with Europe

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.

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