FDA Requires Premarket|OK for Heart Bypass Device

     WASHINGTON (CN) – The FDA will prohibit the marketing of three medical devices if their manufacturers do not file a premarket approval application or a notice of completion of a product development protocol, according to a new regulation.


The Food and Drug Administration paperwork, generally, must be filed within 90 days.
     The devices are: the ventricular bypass (assist) device; pacemaker repair or replacement material; and the female condom.
     Manufacturers must follow certain rules for devices, such as these, that have been in commercial distribution since before Congress changed the rules for marketing new medical devices, in 1976.
     If the paperwork is not filed in time, the devices will be considered “adulterated,” and the FDA may seize and condemn devices distributed after the deadline has passed, according to the new regulation. Also, shipment in interstate commerce would be enjoined, and those responsible for the shipments would be subject to prosecution. In the past, the FDA also has requested that manufacturers take action to prevent the further use of devices for which no premarket approval application has been filed, according to the new regulation.
     No extensions of the deadline are granted, because manufacturers and importers would have known for 2.5 years that premarket approval would be required. The House Report on the 1976 rule changes states that “* * * [t]he thirty month `grace period’ afforded after classification of a device into class III * * * is sufficient time for manufacturers and importers to develop the data and conduct the investigations necessary to support an application of premarket approval,” according to the FDA’s new regulation.
     Click the document icon for this regulation and others.
     

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