Medical devices; effective date of requirement for premarket approval for three class III preamendments devices--FDA. Proposed rule; opportunity to request a change in classification.
The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following three class III preamendments devices: Lung water monitor, powered vaginal muscle stimulator for therapeutic use, and stair-climbing wheelchair. The agency also 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 that the agency change the classification of any of the devices based on new information. This action implements certain statutory requirements.
D000776:Anesthesiology / Q000295:instrumentation*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004558:Electric Stimulation; D004869:Equipment Safety; D015633:Extravascular Lung Water; D005260:Female; D006801:Humans; D009774:Obstetrics / Q000295:instrumentation*; D026741:Physical Therapy Modalities / Q000295:instrumentation*; D020018:Sexual Dysfunctions, Psychological; D014481:United States; D014486:United States Food and Drug Administration; D014910:Wheelchairs