The FDA proposed requiring the filing of a premarket approval application or a notice of product development protocol for the Class III preamendments device implantable pacemaker pulse generator, according to a proposal published July 27 in the Federal Register.
The agency is summarizing its proposed findings regarding risk of illness or injury, which are designed to be eliminated as a result of the proposed approval requirements, and defining benefits to the public from the use of the device. Any interested parties are welcome to request the FDA change classification of the device based on new information, according to the proposed rule. Requests for classification change must be received by Aug. 11, and electronic or written comments must be received by Oct. 25.
An implantable pacemaker pulse generator is a device that contains a battery and electronic circuits that produce a periodic electrical pulse to stimulate the heart. The Cardiovascular Devices Panel recommended that the implantable pacemaker pulse generator—including the internal battery—be classified into Class III because the device is implanted, life-supporting and presents a potential unreasonable risk of illness or injury. Although a proposed standard had previously been written regarding the device, the panel found that it did not cover all of the performance characteristics.
“Consequently, the panel believed that premarket approval was necessary to assure the safety and effectiveness of the device. The FDA continues to agree with the panel’s recommendation,” the proposal states.
Among some of the potential risks to health, the panel found: failure to pace, improper pacing rate, arrhythmias, improper sensing, tissue damage, unintended stimulation, development of pacemaker syndrome and other complications.
If enacted, the rule would require that a premarket approval include detailed discussion of those risks, description of the effectiveness of the device, as well as full reports of all preclinical and clinical investigations. A product development protocol may be submitted in lieu of a premarket approval, according to the agency, which must provide a description of the device, preclinical trial information, clinical trial information, description of manufacturing processes, the device labeling and all other relevant information.
“The Agency proposes to certify that the proposed rule, if issued as a final rule, would not have a significant economic impact on a substantial number of small entities,” the proposal states. “We specifically request detailed comment regarding the appropriateness of our assumptions regarding the potential economic impact of this proposed rule.”
The proposal can be found here.