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# Testing for Biotin Interference in IVDS
- URL: https://www.fdaweb.com/testing-for-biotin-interference-in-ivds/
- Published: 2019-06-14T12:00:00.000Z
- Updated: 2026-09-15T01:32:50.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144343

*Federal Register* notice: FDA has made available a draft guidance entitled “Testing for Biotin Interference in *In Vitro* Diagnostic Devices.” The document provides FDA’s recommendations on the testing for interference by biotin on the performance of *in vitro* diagnostic devices. It is intended to help device developers and clinicians understand how FDA recommends biotin interference testing should be performed and how the results of the testing should be communicated to end users, including clinical laboratories and clinicians. FDA also recommends that manufacturers of currently marketed devices consider these draft recommendations. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-06-14/pdf/2019-12564.pdf?ref=fdaweb.com).