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# Diagnostic Device Biotin Interference Guidance
- URL: https://www.fdaweb.com/diagnostic-device-biotin-interference-guidance/
- Published: 2019-06-13T12:00:00.000Z
- Updated: 2026-09-15T01:32:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144326

FDA is publishing a draft guidance, *Testing for Biotin Interference in In Vitro Diagnostic Devices*, with agency recommendations. The [document](https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-12564.pdf?ref=fdaweb.com) is intended to help medical device developers and clinicians understand how the agency recommends biotin interference testing should be performed and how the results of testing should be communicated to end users, including clinical laboratories and clinicians. FDA also recommends that manufacturers of currently marketed devices consider the draft recommendations.

In a 2017 [safety communication](https://www.fda.gov/medical-devices/safety-communications/fda-warns-biotin-may-interfere-lab-tests-fda-safety-communication?ref=fdaweb.com), FDA said that many labs use biotin technology due to its ability to bond with specific proteins that can be measured to detect certain conditions. However, it said, biotin in blood or other samples taken from patients who are ingesting high levels of biotin in dietary supplements can cause clinically significant incorrect lab test results. “FDA has seen an increase in the number of reported adverse events, including one death, related to biotin interference with lab tests,” the communication said.