Medical devices; effective date of requirement for premarket approval for three class III preamendments physical medicine 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 product development protocol (PDP) for the following three high priority Group 3 preamendments class III devices: Microwave diathermy for uses other than treatment of select medical conditions such as relief of pain, muscle spasms, and joint contractures; ultrasonic diathermy for uses other than treatment of select medical conditions such as relief of pain, muscle spasms, and joint contractures; and ultrasound and muscle stimulator for uses other than treatment of select medical conditions such as relief of pain, muscle spasms, and joint contractures. The uses of these three devices do not include use for the treatment of malignancies. 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 these devices based on new information.
D018795:Device Approval / Q000331:legislation & jurisprudence*; D003972:Diathermy / Q000295:instrumentation / Q000592:standards; D004864:Equipment and Supplies / Q000145:classification* / Q000592:standards; D006801:Humans; D008872:Microwaves; D026741:Physical Therapy Modalities / Q000295:instrumentation*; D014464:Ultrasonic Therapy / Q000295:instrumentation / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration