Medical devices; effective date of requirement for premarket approval for three preamendment class III devices. Food and Drug Administration, HHS. Final rule.
The Food and Drug Administration (FDA) is issuing a final rule to retain three class III preamendment devices in class III and to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following devices: The lung water monitor, the powered vaginal muscle stimulator, and the stair-climbing wheelchair. 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.
D018795:Device Approval / Q000331:legislation & jurisprudence*; D004558:Electric Stimulation; D004867:Equipment Design; D004869:Equipment Safety; D015633:Extravascular Lung Water; D005260:Female; D006801:Humans; D009774:Obstetrics / Q000295:instrumentation; D026741:Physical Therapy Modalities / Q000295:instrumentation; D014481:United States; D014486:United States Food and Drug Administration; D014910:Wheelchairs