The FDA has issued draft guidance that would lower the risk classification for external pacemaker pulse generators from Class III to Class II.
“The FDA has assessed the benefits and risks of external pacemaker pulse generators,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health (CDRH). “The special controls outlined in this draft guidance, along with general controls, will assure the safety and efficacy of these devices and provide manufacturers with a more predictable path to market.”
In addition to compliance with general controls—which include good manufacturing practice requirements, labeling, registering with the FDA, listing devices and submitting a premarket notification—Class II devices are also subject to special controls, which may include special labeling requirements, mandatory performance standards and postmarket surveillance, according to the FDA.
External pacemakers are preamendment devices, as they existed on the market prior to the Medical Device Amendments Act of 1976, and continued to be reviewed under the 510(k) program because the FDA did not issue regulations requiring applications for premarket approval.
The agency has set Jan. 17 as the due date for comments on the draft guidance.