Medical devices; retention in class III and effective date of requirement for premarket approval for three preamendments class III devices--FDA. Proposed rule; opportunity to request a change in classification.
The Food and Drug Administration (FDA) is proposing to retain in class III, three preamendments class III medical devices, and is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for these devices. FDA believes that the suction antichoke device, the tongs antichoke device, and the implanted neuromuscular stimulator device should remain in class III because insufficient information exists to determine that special controls would provide reasonable assurance of their safety and effectiveness, and/or these devices present a potential unreasonable risk of illness or injury. The agency is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. In addition, FDA is announcing the opportunity for interested persons to request the agency to change the classification of any of the devices based on new information.
D000402:Airway Obstruction / Q000628:therapy; D002985:Clinical Protocols; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004566:Electrodes; D004864:Equipment and Supplies / Q000145:classification* / Q000592:standards; D006801:Humans; D009468:Neuromuscular Diseases / Q000628:therapy; D019919:Prosthesis Implantation / Q000295:instrumentation / Q000592:standards; D012307:Risk Factors; D013396:Suction / Q000295:instrumentation; D013525:Surgical Instruments / Q000145:classification / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration