Sec. 3057. CLIA WAIVER IMPROVEMENTS
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## SEC. 3057 CLIA WAIVER IMPROVEMENTS **[**[42 U.S.C. 263a note](/us/usc/t42/s263a)**]** ###
(a)Draft Revised Guidance Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish a draft guidance that— ####
(1)revises “Section V. Demonstrating Insignificant Risk of an Erroneous Result - Accuracy” of the guidance entitled “Recommendations for Clinical Laboratory Improvement Amendments of 1988
(CLIA)Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” and dated January 30, 2008; and ####
(2)includes the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy. ###
(b)Final Revised Guidance The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall finalize the draft guidance published under subsection
(a)not later than 1 year after the comment period for such draft guidance closes.
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Sec. 3057
CLIA WAIVER IMPROVEMENTS
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