WASHINGTON (CN) – The Food and Drug Administration plans to reclassify the external pacemaker, so manufacturers have to follow “special controls” in a guidance document instead notifying the FDA when the manufacturer will be marketing the product.
An external pacemaker is used as a temporary substitute for the heart’s intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a heart attack. It produces a periodic electrical pulse to make the heart pump blood.
In 2009, the FDA requested information on the devices, and it received reclassification petitions from three device manufacturers. The manufacturers stated that safety and effectiveness of these devices may be assured by design and maintenance (special controls), consideration of risks involved with the device, and an independent verification that appropriate standard operating procedures are in place and being followed.
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