In a hearing in the House of Representatives, several GOP lawmakers criticized the FDA approval process, saying it was easier to get devices approved in Europe. They noted that some device makers have even closed U.S. operations after their products were denied FDA approval.
Rep. Erik Paulsen (R-Minn.) noted that Acorn Cardiovascular 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.
Read the Bedford Report Release on medical device companies.
Related Articles on Medical Device Companies:
FDA Device Approval Process Stifles Innovation, Industry Survey Finds
Congressman Criticizes FDA Delays for Device Approvals
GAO Publishes Report on FDA’s Premarket Review and Postmarket Safety Efforts
