Draft clinical guidance for the preparation and contents of an Investigational Device Exemption (IDE) application for excimer laser devices used in ophthalmic surgery for myopic photorefractive keratectomy (PRK). Office of Device Evaluation, Division of Ophthalmic Devices, Food and Drug Administration.
D002986:Clinical Trials as Topic / Q000592:standards; D003315:Cornea / Q000601:surgery*; D004282:Documentation; D053685:Laser Therapy; D009216:Myopia / Q000601:surgery*; D012107:Research Design / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration