Medical device vigilance at FDA
Gross, T.P.; Kessler, L.G.
Studies in Health Technology and Informatics 28: 17-24
1996
ISSN/ISBN: 0926-9630 PMID: 10164091 Document Number: 467257
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.