Client Alert: FDA Issues Order Requiring Safety and Effectiveness Information from Older Medical Devices


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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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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