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# Device Biotin Interference Testing Guidance
- URL: https://www.fdaweb.com/device-biotin-interference-testing-guidance/
- Published: 2020-10-16T12:00:00.000Z
- Updated: 2026-09-14T16:32:56.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147891

Federal Register notice: FDA makes available a final guidance entitled *Testing for Biotin Interference in In Vitro* *Diagnostic Devices*. The document provides recommendations on testing for interference by biotin on the performance of *in vitro* diagnostic devices (IVDs). It is intended to help device developers and clinicians understand how the agency recommends biotin interference testing be performed, and how the results of the testing should be communicated to end-users, including clinical laboratories and clinicians. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-10-16/pdf/2020-22926.pdf?ref=fdaweb.com).