(RxWiki News) U.S. Food and Drug Administration officials are contemplating a proposal to lower the risk classification of external pacemakers from the highest risk category to labeling them a moderate risk.
External pacemakers were on the market before a 1976 Medical Device Amendments Act, and were automatically deemed Class III devices. The effort to move them to the lower Class II is considered a rule clarification.
"This rule change should have no impact on patients."
External pacemaker pulse generators are generally used to temporarily regulate a patient's heartbeat until implantation of an internal pacemaker. They also can be used after heart surgery or following a heart attack to control irregular heartbeats.
Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said the FDA has assessed the benefits and risks of external pacemakers. She said controls outlined in the draft proposal will assure safety and efficacy of the devices while also giving manufacturers a more predictable path to market.
Those controls include good manufacturing practice, labeling, registering all establishments with the FDA, listing all devices to be marketed and submitting a premarket notification before marketing a device.
As a class II device, the external pacemakers also would be subject to special labeling requirements, performance standards and surveillance after they are marketed.
External pacemakers are one of 22 remaining class III preamendment medical devices regulated through 510(k) premarket submission rather than the premarket approval required for other class III devices. This was because they were introduced prior to the 1976 act.