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Diane Publishing Books
Medical Devices: FDA Has Met Most Performance Goals but Device Reviews Are Taking Longer
Marcia Crosse (au)
The Food and Drug Admin. (FDA) within the Dept. of Health and Human Services (HHS) is responsible for overseeing the safety and effectiveness of medical devices sold in the U.S. New devices are generally subject to FDA review via the 510(k) process, which determines if a device is substantially equivalent to another legally marketed device, or the more stringent premarket approval (PMA) process, which requires evidence providing reasonable assurance that the device is safe and effective. FDA has been authorized to collect user fees from the medical device industry to support the process of reviewing device submissions. FDA also committed to performance goals that incude time frames within which FDA is to take action on a proportion of medical device submissions. This report (1) examines trends in FDAäó»s 510(k) review performance from FY2003-2010; (2) examines trends in FDAäó»s PMA review performance from FYs 2003-2010; and (3) describes stakeholder issues with FDAäó»s review processes and steps FDA is taking that may address these issues. Tables and figures. This is a print on demand report.
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