The Urgent Care Association is one of numerous organizations that have filed comments regarding a draft Food and Drug Administration Guidance on CLIA-waived tests. UCA, and others, charge that the spirit of Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices runs counter to the intent expressed by Congress in passing the amendment. For one thing, they maintain, the FDA must remove proposed discussion …
Read More