FDA Requires Premarket Approval for Pacemaker Pulse Generators & Programmers by Sept. 20
A premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) will be required for pacemaker pulse generators and pacemaker programmers, said the Food and Drug Administration in two final rules.
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Under the final rules, a PMA or a notice of completion of a PDP is required to be filed by Sept. 20 for any class III “preamendments” pacemaker pulse generator or pacemaker programmer 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 Sept. 20, 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 pulse generator or pacemaker programmer 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 Sept. 20 will result in the device being deemed adulterated.
(FDA said it mistakenly said in its proposed rule on pacemaker programmers that PMAs and PDPs for such devices should be submitted by Nov. 2, 2011. Rather, FDA said, PMAs and PDPs should be submitted by Sept. 20.)
FDA final rule on pacemaker pulse generators (FR Pub 06/22/12) available here.
FDA final rule on pacemaker programmers (FR Pub 06/22/12) available here.