More applications, but approvals flat

July 2008
Cardiovascular Devices & Drugs;Jul2008, Vol. 14 Issue 7, p27
The article reports on the approvals issued by the Office of Device Evaluation (ODE) at the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health in 2006 and 2007. The approvals made by the ODE remain flat despite a 9% increase in applications and submissions related to medical devices. Device manufacturers complain that the user fees that they paid for have not benefited them. It examines the trends within the ODE concerning major submissions which include premarket approval applications (PMAs).


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