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This article was originally published in The Gray Sheet

Executive Summary

Comments are due within 30 days of the March 1 publication in the Federal Register of the Medical Devices Draft Guidance for Clinical Laboratory Improvement Amendments of 1988 Criteria for Waiver. The guidance includes an alternate path to waiver based on user comparability criteria, but also retains methods laid out in the 1995 proposed rule (1"The Gray Sheet" Jan. 29, 2001, p. 3)
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