Medical devices; retention of three preamendment class III devices in class III--FDA. Final rule.
The Food and Drug Administration (FDA) is retaining the following three preamendments class III devices in class III: Lung water monitor, powered vaginal muscle stimulator for therapeutic use, and stair-climbing wheelchair. The agency is taking this action 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.
D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety; D014481:United States; D014486:United States Food and Drug Administration