The Food and Drug Administration (FDA) has published two draft guidance documents to help in vitro diagnostic manufacturers apply for and receive CLIA waivers. The first draft guidance document encompasses the appropriate use of comparable performance between a user in a waived facility and a user in a moderately complex laboratory to demonstrate accuracy. When finalized, this content will update Section V of the 2008 guidance, “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.” The second draft guidance document, “Recommendations for Dual 510(k) and CLIA Waiver by Application Studies,” describes the agency’s expectations regarding study designs for generating data that supports both 510(k) clearance and CLIA Waiver by Application. FDA hopes that increased use of this dual pathway will speed up the process of bringing diagnostic devices to CLIA waived settings. FDA is seeking feedback on both draft guidance documents through January 29, 2018. Comments can be submitted at