Section 1 CLIA waiver study design guidance for in vitro diagnostics
Draft revised guidance— Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall publish a draft guidance that—
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
includes guidance on the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy.
Final revised guidance— The Secretary of Health and Human Services shall finalize the draft guidance published under subsection (a) not later than 12 months after the comment period for such draft guidance closes.