Rep. Fred Upton (R-Mich.), chairman of the House Energy and Commerce Committee, accused the FDA of squashing innovation by overregulating the device industry, according to a report by Dow Jones.
In a hearing interrogating Jeffrey Shuren, FDA director of the Center for Devices and Radiological Health, Rep. Upton said the center was risking the United States' leadership position on medical devices. He noted the center typically takes longer to approve devices than the European Union.
Mr. Shuren said the EU does not require a devicemaker to specify how a product benefits patients. But he admitted the center needs better training for reviewers, improved oversight and better staff guidance on benefits and risks of devices.
Read the Dow Jones report on FDA medical device regulation.
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