Medical Devices; Retention in Class III and Effective Date of Requirement for Premarket Approval for Three Preamendment Class III Devices

Samenvatting

The Food and Drug Administration (FDA) is issuing a final rule to retain in class III, three preamendment medical devices and to require the filing of a premarket approval application (PMA) or a notice of completion of product development protocol (PDP) for the suction antichoke device, the tongs antichoke device, and the implanted neuromuscular stimulator. The agency has summarized its 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. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).