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Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices." FDA has developed this draft guidance to implement the 21st Century Cures Act (the Cures Act), which requires FDA to revise "Section V. Demonstrating Insignificant Risk of an Erroneous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. This draft guidance represents FDA's current thinking regarding "the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy." The 2008 CLIA Waiver Guidance remains in effect, in its current form, until this draft guidance is finalized, at which time the updates in section III of this draft guidance will supersede the recommendations in section V of the 2008 CLIA Waiver Guidance. This draft guidance is not final nor