Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

Zusammenfassung

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices." FDA has updated this guidance to implement the waiver improvements section of the 21st Century Cures Act (the Cures Act), which requires FDA to revise "Section V. Demonstrating Insignificant Risk of an Erroneous Result--Accuracy" of the guidance "Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices" ("2008 CLIA Waiver Guidance") that was issued on January 30, 2008. The remainder of the 2008 CLIA Waiver Guidance, with exception of technical edits for consistency with the newly amended section V, has not been substantively changed. This final guidance provides additional and updated approaches for demonstrating that a test meets the statutory criteria for waiver and includes FDA's revised thinking regarding "the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accurac