Medical device vigilance at FDA.
This overview of medical device vigilance at the U.S. Food and Drug Administration (FDA) discusses the basic reporting regulation and program at FDA. The FDA program has grown to the point where we now receive over 100,000 reports per year. How FDA examines the data patterns in overall reporting, to identify signals in the database, and the potential actions FDA takes to respond to these problems are also presented. New initiatives include, for example, new methods to triage reports and the move developing an internationally harmonised nomenclature.
Gross
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Office of Surveillance and Biometrics, Food and Drug Administration, Rockville, MD 20850, USA.
Kessler
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D016208:Databases, Factual; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration