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.
Related Articles on the FDA Approval Process:
FDA Device Approval Process Stifles Innovation, Industry Survey Finds
GAO Publishes Report on FDA’s Premarket Review and Postmarket Safety Efforts
Medical Device Innovation Center in Atlanta Receives $3.6M
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.