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Temple report followup audit

This article was originally published in The Gray Sheet

Executive Summary

FDA device center begins internal review of "a sample of targeted and randomly selected" device applications to determine the prevalence of data deficiencies identified in the recent Committee for Clinical Review report, according to a June 15 memo to device center staffers. FDA announced plans to conduct the more in-depth audit when the Temple report was released in March ("The Gray Sheet" March 8, p. 1).

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