Home > Newsletters > International Medical Device Regulatory Monitor > EU-Style Device Approval Poses Patient Safety Risks, U.S. FDA Says
International Medical Device Regulatory Monitor
June 2012 | Vol. 20 No. 6
EU-Style Device Approval Poses Patient Safety Risks, U.S. FDA Says
Manufacturers hoping the U.S. Food and Drug Administration (FDA) might adopt a more European-style approach to device approval got a strongly negative signal in a May agency report. Includes the full text of U.S. FDA Report on Devices Approved in the EU but Not in the U.S.
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