CLIA WAIVER IMPROVEMENTS.

SEC. 3057. [42 U.S.C. 263a note] CLIA WAIVER IMPROVEMENTS. (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Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish a draft guidance that— (1) revises “Section V. Demonstrating Insignificant Risk of an Erroneous Result - Accuracy” of the guidance entitled “Recommendations for Clinical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Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall finalize the draft guidance published under subsection (a) not later than 1 year after the comment period for such draft guidance closes.