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CLIA Guidance

This article was originally published in The Gray Sheet

Executive Summary

FDA is extending to April 14, 1993 the comment period for a draft guidance document for manufacturers of in vitro diagnostic devices and biologics, according to a notice in the March 5 Federal Register. The draft guidance, released Jan. 12, describes when and how to obtain complexity categorizations and clearance of quality control instructions for tests under the Clinical Laboratory Improvement Amendments of 1988 ("The Gray Sheet" Jan. 18, p. 3). The comment period was originally set to expire March 15.
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