Medical devices; exemptions from premarket notification; class II devices. Final rule.
The Food and Drug Administration (FDA) is publishing a final rule exempting from the premarket notification requirements the fluoroscopic compression device, a manual compression device that allows a radiologist to press on the abdomen during a fluoroscopic procedure without exposing his or her hand to the x-ray beam. The device is classified as an accessory to the image-intensified fluoroscopic x-ray system. FDA received a petition requesting an exemption for the F-Spoon device, a type of fluoroscopic manual compression device. FDA is expanding the exemption for this type of generic device to include other fluoroscopic compression devices. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).
D018795:Device Approval; D004867:Equipment Design; D004869:Equipment Safety; D005471:Fluoroscopy / Q000145:classification / Q000295:instrumentation*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration