Zdrowie i gospodarka · 09/04/2009

FDA Orders Manufacturers of Remaining Class III Devices to Submit Safety and Effectiveness Information

The FDA is requiring manufacturers of remaining preamendments class III devices to submit a summary of any known adverse safety or effectiveness information, as well as a citation to such information, in order to determine if the device's classification should be revised to require premarket approval or a notice of completion of a Product Development Protocol.