FDA Issues Order Requiring Safety And Effectiveness Information From Older Medical Devices

Mondaq Business BriefingUnited States Law Articles in English (2009)

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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 t...

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