The guidance, posted in the Federal Register, reported that a panel of investigators found proposed standards for implantable pacemakers were not widely accepted and premarket approval was necessary to ensure the safety and effectiveness of the devices.
The panel recommended premarket approval applications include detailed data on risks and effectiveness and full reports of all clinical and preclinical information.
Read the FDA report on proposed new premarket approval rules for implantable pacemaker pulse generators.
Articles on Implantable Devices:
Publication Ranks 11 Most Implanted Medical Devices
Researcher Proposes Using Blood to Fuel Implantable Devices
Zoll Gets FDA Warning Letter on Defibrillator Battery Life
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