FDA Finalizes Clinical Laboratory Guidance Documents for In Vitro Diagnostic Tests

The FDA recently released two final guidance documents that provide recommendations for Clinical Laboratory Improvement Amendment (CLIA) waivers – one titled “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostics Devices” (CLIA guidance) and the other titled “Recommendations for Dual 510(k) and CLIA Waiver by Application Studies” (dual guidance). The ability to rely on the same studies for both applications should be more efficient for test developers.