GAO urges FDA to require PMA for all class III devices
Device Regulation Alert: Safety, Compliance and Reimbursement News, January 26, 2009
Medical device manufacturers may soon be required to submit all class III devices to the more stringent pre-market approval (PMA) process instead of the 510(k) pre-market notification process.
New devices must clear FDA pre-market review through either the 510(k) pre-market notification process, which determines whether a new device is substantially equivalent to another legally marketed device, or the PMA process, which requires the manufacturer to supply evidence that the device is safe and effective. The Safe Medical Devices Act of 1990 required that FDA either reclassify or establish a schedule for requiring PMAs for class III devices.
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