Medical device reporting for user facilities.
Reprinted from a report by the Center for Devices and Radiological Health, this article answers questions about the "tentative final rule," which outlines medical device reporting requirements for user facilities, distributors and manufacturers. Besides providing general information about the proposed regulation, the article describes which facilities are affected, which device-related incidents must be reported and how to report them.
D004282:Documentation / Q000592:standards; D004868:Equipment Failure; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards*; D006268:Health Facilities / Q000331:legislation & jurisprudence*; D058016:Health Facility Administration; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration