Regulatory aspects of ultrasound-assisted lipoplasty.
In our litigious medical environment, and particularly after the breast implant debacle, plastic surgeons must understand the regulatory implications of devices they implant in their patients. This article reviews the regulatory aspects of ultrasound-assisted lipoplasty and the regulatory fundamentals that apply to all new technology and devices.
D018795:Device Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D015187:Lipectomy / Q000295:instrumentation*; D014464:Ultrasonic Therapy / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration