On April 9, 2009, the Food and Drug Administration (FDA, or the Agency) issued an order that requires manufacturers of 25 high risk Class III medical devices, which were marketed before 1976 but have not yet undergone the premarket approval (PMA) review process, to submit safety and effectiveness information to the Agency. 74 Fed. Reg. 16214-17 (Apr. 9, 2009). The Agency will use this information to determine, for each device, whether the device's classification should be revised to require a PMA application or notice of completion of a Product Development Protocol (PDP)—the most stringent premarket review processes for medical devices—or whether the device should be reclassified as a lower-risk class I or II device.
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