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# Guide on CLIA Waiver for IVD Devices
- URL: https://www.fdaweb.com/guide-on-clia-waiver-for-ivd-devices/
- Published: 2020-02-26T12:00:00.000Z
- Updated: 2026-09-14T16:04:36.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5146183

*Federal Register* notice: FDA has made available a final guidance entitled “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.” The document discusses FDA’s thinking on implementing waiver improvements mandated by the section of the 21st Century Cures Act. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-02-26/pdf/2020-03860.pdf?ref=fdaweb.com).