Medical devices; general and plastic surgery devices; classification of the low energy ultrasound wound cleaner. Final rule.
The Food and Drug Administration (FDA) is classifying the low energy ultrasound wound cleaner into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for the class II device.
D003646:Debridement / Q000145:classification / Q000295:instrumentation*; D018795:Device Approval / Q000331:legislation & jurisprudence; D004869:Equipment Safety / Q000145:classification; D017408:Guidelines as Topic; D006801:Humans; D009330:Nebulizers and Vaporizers / Q000145:classification; D014464:Ultrasonic Therapy / Q000145:classification / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration; D014945:Wound Healing