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MDR trending analysis guidance

This article was originally published in The Gray Sheet

Executive Summary

FDA puts on hold an effort to develop a document to assist manufacturers in identifying trends in medical device reports. FDA staffers say problems have been encountered in developing guidance general enough to cover all situations. The agency announced it would develop the document in July 1992 ("The Gray Sheet" July 20, p. 3). Trend analysis will be required under MDR regs being finalized.
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