Medical devices; exemptions from premarket notification; surgical lamps--FDA. Notice.
The Food and Drug Administration (FDA) is publishing an order denying a petition requesting an exemption from the premarket notification requirements for surgical lamps. FDA is publishing this notice in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards; D004869:Equipment Safety; D006801:Humans; D008029:Lighting / Q000331:legislation & jurisprudence* / Q000592:standards; D013523:Surgical Equipment / Q000592:standards*; D014466:Ultraviolet Rays / Q000009:adverse effects; D014481:United States; D014486:United States Food and Drug Administration