Assayed and unassayed quality control material
This article was originally published in The Gray Sheet
Executive Summary
Comments on FDA's draft guidance document on the materials published in the Feb. 3 Federal Register are due within 90 days. FDA specifically requests input on the document's recommendation that sponsors evaluate control materials for the effects of the materials being tested. "New and unusual non-human matrices (materials such as blood, serum, or urine from animals) are becoming more common" and FDA "believes it is important for the user to know if a matrix bias exists." The agency also seeks comments on its suggestion that each QC material be evaluated for its "ability to detect variables in assay conditions that have an impact on patient sample results"
You may also be interested in...
QC guidance
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)...
‘Clear’ Is In The Eye Of The Beholder, New York, CRN Argue In Age-Restricted Sales Litigation
CRN’s request for clarification, as it continues litigating complaint in US District Court for Southern New York, highlights what it contends is vague and overly general language in the legislation passed in October with a 22 April effective date.