To amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnostics.

This bill requires the Department of Health and Human Services to publish guidance that revises “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” and includes guidance on using comparable performance between types of users to demonstrate the accuracy of a medical device.