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The Food and Drug Administration on Wednesday required manufacturers of 25 types of medical devices marketed prior to 1976 to submit within 120 days safety and effectiveness information so the agency can evaluate the risk level for each type of device.
The devices include external and implantable pacemaker pulse generators, pacemaker programmers, automated external defibrillators, and electroconvulsive therapy devices.
The FDA said their manufacturers must submit for devices covered by the order a summary of, and citation to, "any information known or otherwise available to them respecting the devices, including adverse safety and effectiveness data that has not been submitted under section 519 of the act.”
The FDA’s request is the first step towards completing the review of Class III device types predating the 1976 law, as was recommended by the U.S. Government Accountability Office (GAO) in a January 2009 report to Congress.
“We are taking the necessary steps to complete this very complex process while continuing to protect public health by thoroughly reviewing and evaluating all medical device submissions presented to the agency. New premarket notification submissions for devices of these 25 types will continue to receive an appropriate level of scrutiny to ensure safety and effectiveness,” said Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health.
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