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# Guide on CLIA Waivers for IVD Devices
- URL: https://www.fdaweb.com/guide-on-clia-waivers-for-ivd-devices/
- Published: 2017-11-29T12:00:00.000Z
- Updated: 2026-09-14T23:03:55.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140229

*Federal Register* notice: FDA has made available a draft guidance entitled “Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.” The document updates FDA’s thinking on the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-11-29/pdf/2017-25775.pdf?ref=fdaweb.com).