The purpose of this guidance is to assist manufacturers in using the Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application pathway. It describes study designs for generating data that may support both 510(k) clearance and CLIA waiver. Use of the Dual 510(k) and CLIA Waiver by Application pathway is optional; however, FDA believes this pathway is in many instances the least burdensome and fastest approach for manufacturers to obtain a CLIA waiver at the same time as 510(k) clearance for new In Vitro Diagnostic (IVD) tests. FDA believes increased use of this pathway will speed up the process of bringing simple and accurate IVD tests to CLIA-waived settings, which will better serve patients and providers.

For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database.