FDA Releases Draft Guidance for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for In Vitro Diagnostic Devices

Summary

The Food and Drug Administration (FDA) has published a draft guidance to update its recommendations for manufacturers of in vitro diagnostic devices, aligning with the 21st Century Cures Act and implementing changes to the 2008 Clinical Laboratory Improvement Amendments of 1988 waiver guidance, which remains in effect until the draft is finalized.