Guidance for the emergency use of unapproved medical devices; availability--FDA. Notice.
The Food and Drug Administration (FDA) is announcing guidance, developed by FDA's Center for Devices and Radiological Health (CDRH), with respect to those emergency situations in which the agency would not object to a physician's using a potentially life-saving medical device for a use for which the device ordinarily is required to have, but does not have, an approved application for premarket approval or an investigational device exemption. The guidance is contained in a document entitled "guidance for the Emergency Use of Unapproved Medical Devices."
D004630:Emergencies; D004864:Equipment and Supplies / Q000592:standards*; D006268:Health Facilities; D014481:United States; D014486:United States Food and Drug Administration