FDA Requires Premarket Approval for Permanent Pacemaker Electrodes by Oct. 4
A premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) will be required for cardiovascular permanent pacemaker electrodes, said the Food and Drug Administration in a final rule.
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Under the final rules, a PMA or a notice of completion of a PDP is required to be filed by about Oct. 4 for any class III “preamendments” pacemaker electrode that was in commercial distribution before May 28, 1976, or that has been found by FDA to be substantially equivalent to such a device on or before Oct. 4, said FDA. An approved PMA or a declared completed PDP is required to be in effect for any such devices on or before 180 days after FDA files the application, it said. Any other class III preamendments pacemaker electrode that was not in commercial distribution before May 28, 1976, is required to have an approved PMA or a declared completed PDP in effect before it may be marketed.
FDA said failure to file a PMA or complete a PDP for these devices by 90 days after the effective date of Oct. 4 will result in the device being deemed adulterated.