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Diane Publishing Books
Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types are Approved through the Most Stringent Premarket Review Process
Marcia Crosse (au)
The FDA is responsible for oversight of medical devices sold in the U.S. Regulations place devices into 3 classes, with class III including those with the greatest risk to patients. New devices must clear FDA premarket review via either the 510(k) premarket notification process, which determines if a new device is substantially equivalent to another legally marketed device, or the more stringent premarket approval (PMA) process, which requires the manufacturer to supply evidence providing reasonable assurance that the device is safe and effective. This report examined which premarket review process -- 510(k) or PMA -- FDA used to review selected types of device submissions in FY 2003 through FY 2007. Includes recommendations. Illus.
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