Bill > HR2443

This bill requires the Department of Health and Human Services to update existing guidance for manufacturers seeking a CLIA waiver, which is a process allowing certain medical tests to be performed in less complex laboratory settings. Specifically, the bill mandates the publication of draft revised guidance within 12 months of enactment, which will update the "Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices" and include instructions on how to use comparable performance data between different types of users, such as a typical user of a home testing kit and a moderately complex laboratory user, to prove the accuracy of an in vitro diagnostic device, which are tests performed on samples like blood or urine to detect diseases or conditions. The final guidance must be published within 12 months after the public comment period for the draft closes.