UCA Advocates for Urgent Care in Comments on FDA CLIA Draft Guidance

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 of accuracy and focus more on whether trained and untrained users will each get comparable results when using the same to-be-waived test. In the eyes of Congress—and experts in various care settings—a practice should be entitled to a waiver if both trained and untrained users get comparable results to the same simple tests. Ensuring the language of the guidance reflects that would more correctly frame the value of expanded access to new CLIA-waived tests.