Effective date of requirement for premarket approval for cardiovascular permanent pacemaker electrode. Final rule.
The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the cardiovascular permanent pacemaker electrode. The Agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the statute's approval requirements and the benefits to the public from the use of the device. This action implements certain statutory requirements.
D018795:Device Approval / Q000331:legislation & jurisprudence*; D004567:Electrodes, Implanted / Q000145:classification* / Q000592:standards; D004869:Equipment Safety / Q000145:classification* / Q000592:standards; D006801:Humans; D010138:Pacemaker, Artificial / Q000145:classification* / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration