FDA proposes new requirement for pacemaker programmers
The FDA has proposed requiring a premarket approval application for certain Class III pacemaker programmers.
In calling for the new step, the administration cited the potential risk for problems caused by devices lacking premarket approval, which included cardiac arrhythmias, electrical shock, improper pacemaker operation, misdiagnosis and inability to change pacing therapy.
The administration welcomes input from interested parties on the proposal. Written comments should be received by the administration by Nov. 2, and requests for a change in classification should be received by Aug. 19.
The recent proposal from the FDA comes nearly a week after a similar proposal regarding implantable pacemakers.
A pacemaker programmer is a device used to noninvasively change one or more of the electrical operating characteristics of a pacemaker, according to the agency. The Cardiovascular Device Classification Panel recommended the programmer be classified as Class III, based on the recommendation that pacemakers also be classified in the same category.
“The panel believed that premarket approval of pacemakers was necessary for both devices because pacemaker programmers must be designed to operate with a specific pacemaker as a system,” the authors wrote. “The panel believed that general controls alone would not provide sufficient control over the performance characteristics of this device, that a performance standard would not provide reasonable assurance of the safety and effectiveness of the device, and, moreover, that there are insufficient data to establish a standard to provide such assurance.”
The full proposal can be found here.
In calling for the new step, the administration cited the potential risk for problems caused by devices lacking premarket approval, which included cardiac arrhythmias, electrical shock, improper pacemaker operation, misdiagnosis and inability to change pacing therapy.
The administration welcomes input from interested parties on the proposal. Written comments should be received by the administration by Nov. 2, and requests for a change in classification should be received by Aug. 19.
The recent proposal from the FDA comes nearly a week after a similar proposal regarding implantable pacemakers.
A pacemaker programmer is a device used to noninvasively change one or more of the electrical operating characteristics of a pacemaker, according to the agency. The Cardiovascular Device Classification Panel recommended the programmer be classified as Class III, based on the recommendation that pacemakers also be classified in the same category.
“The panel believed that premarket approval of pacemakers was necessary for both devices because pacemaker programmers must be designed to operate with a specific pacemaker as a system,” the authors wrote. “The panel believed that general controls alone would not provide sufficient control over the performance characteristics of this device, that a performance standard would not provide reasonable assurance of the safety and effectiveness of the device, and, moreover, that there are insufficient data to establish a standard to provide such assurance.”
The full proposal can be found here.