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)...