The FDA has proposed a draft guidance to lower the risk classification for external pacemaker pulse generators from class III to class II.
External pacemaker pulse generators are used after heart surgery or heart attack as a bridge until the patient has a permanent pacemaker implanted.
The federal watchdog agency’s proposed move would lower external pacemaker pulse generators from high-risk to moderate-risk medical devices, removing them from the 22 remaining class III preamendment medical devices regulated through 510(k) premarket submission rather than the premarket approval required for other class III devices.
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Changing the classification from high to moderate-risk would not significantly change the FDA’s external review process, but would provide manufacturers with specific guidelines for obtaining 510(k) approval, said the FDA.
"The FDA has assessed the benefits and risks of external pacemaker pulse generators," said Christy Foreman, director at the FDA’s Center for Devices and Radiological Health in prepared remarks. "The special controls outlined in this draft guidance, along with general controls, will assure the safety and efficacy of these devices and provide manufacturers with a more predictable path to market."
Devices listed as "preamendment" are devices that went on the market prior to the Medical Device Amendments Act of 1976.
The FDA started reviewing all class III preamendment devices in 2009.
