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CLIA deadline extension

This article was originally published in The Gray Sheet

Executive Summary

Health Care Financing Administration is aiming to publish in the next few weeks a notice in the Federal Register extending the Sept. 1, 1994 deadline by which all in vitro diagnostic test labeling was supposed to conform to the quality control provisions of the Clinical Laboratories Improvement Amendments of 1988 ("The Gray Sheet" Jan. 10, I&W-6). An extension of two to four years is expected. Under current regs, laboratories can not after Sept. 1 use IVD QC instructions as a substitute for CLIA QC rules unless the labeling is cleared by FDA. HCFA says it will not enforce the provision if the extension is not published before the deadline

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