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# Draft Guide on CLIA Waivers
- URL: https://www.fdaweb.com/draft-guide-on-clia-waivers/
- Published: 2017-11-28T12:00:00.000Z
- Updated: 2026-09-14T23:03:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140214

FDA has released a [draft guidance](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM586506.pdf?ref=fdaweb.com) on “Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.” The document is mandated by the 21st Century Cures Act, which requires FDA to revise “Section V. Demonstrating Insignificant Risk of an Erroneous Result — Accuracy” of the 2008 guidance on *Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices*. It outlines two options for a sequential route for a CLIA waiver in which safety and effectiveness or substantial equivalence is established first, followed by a separate application containing an evaluation of the test’s accuracy in a CLIA-waived setting.