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FDA proposes lower risk classification for external pacemakers
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The FDA has issued a proposed rule and draft special controls guidance lowering the risk classification for external pacemaker pulse generators from Class III to Class II.
External pacemaker pulse generators were placed on the market before the Medical Device Amendments Act of 1976, making them a pre-amendment device still being reviewed under premarket notification because the FDA did not issue regulations requiring applications for premarket approval. The FDA has proposed general controls and special controls, making external pacemaker pulse generators safer and more effective for the temporary treatment of regulating heartbeat and controlling irregular heartbeats.
"The FDA has assessed the benefits and risks of external pacemaker pulse generators," Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, said in a press release. "The special controls outline in this draft guidance, along with general controls, will assure the safety and efficacy of these devices and provide manufacturers with a more predictable path to market."
The proposed rule and draft special controls guidance provide manufacturers with clarity and specific guidance on what information is needed in a premarket notification for external pacemaker pulse generators, although it will not significantly change the FDA's review of the product.
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