Following last week’s draft guidance recommending that pacemakers be reclassified as Class III devices that require premarket approval for FDA review, the watchdog agency released a new proposed rule today that would put the external devices used to alter a pacemaker’s electrical operating performance in the same category.
Pacemaker programmers non-invasively communicate with the implanted device to modify the rate of pacing or other operating characteristics.
The FDA agreed with the cardiovascular device classification panel’s recommendation that the programmers undergo premarket review, citing risks of cardiac arrhythmia or electrical shock, improper pacemaker operation, misdiagnosis and inability to change pacing therapy.
As with the pacemaker guidance, the panel recommended that PMAs be filed for the devices including detailed data on the risks identified by the agency as well as any risks not listed in the guidance, the effectiveness of the device under review and full reports of all clinical and preclinical information on safety and effectiveness.
