CLIA Waiver Applications Update Guidance
FDA has published a draft guidance, Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices, to implement a section of the 21st Century Cures Act requiring the agency to revise Section V, “Demonstrating Insignificant Risk of Erroneous Result—Accuracy” of a 2008 CLIA Waiver guidance. The new draft gives the agency’s current thinking on “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The 2008 CLIA Waiver guidance remains in effect in its current form, the agency says, until the draft guidance is finalized, at which time the updates in the draft will supersede the recommendations in Section V of the 2008 guidance.
This draft includes Introduction and Scope, Background and Rationale, and Revised Section V.