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QC guidance

This article was originally published in The Gray Sheet

Executive Summary

FDA issues a final 1guidance document June 7 on preparing 510(k)s and labeling for assayed and unassayed quality control materials that are intended to monitor reliability of a diagnostic system and help minimize reporting of incorrect results. The document follows a 1999 draft version (2"The Gray Sheet" Feb. 8, 1999, p. 32)...

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