In a hearing, Rep. Erik Paulsen (R-Minn.) criticized FDA delays for approving medical devices, saying they could drive device-makers to Europe and China, according to a report by the Minneapolis Star-Tribune.
In a hearing of the House Government and Oversight Subcommittee, Rep. Paulsen said Acorn Cardiovascular in Minnesota failed to gain FDA approval for a heart failure device after a decade of back-and-forth with the agency and it is now defunct.
Jeffrey Shuren, director of the FDA's Centers for Devices and Radiological Health, acknowledged that improvements in the approval process could be made but warned that they should not hamper efforts to ensure the devices are safe.
Read the Minneapolis Star-Tribune report on the FDA approval process.
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