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# Guide on IVD Biotin Interference Testing
- URL: https://www.fdaweb.com/guide-on-ivd-biotin-interference-testing/
- Published: 2020-10-15T12:00:00.000Z
- Updated: 2026-09-14T16:32:34.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147886

FDA has made available a [final guidance](https://www.fda.gov/media/127915/download?ref=fdaweb.com) 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. 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.  

The recommendations reflect FDA’s thinking that labeling alone may not be sufficient to mitigate the risk of incorrect results from biotin interference in all cases. “Additional mitigation strategies may be considered when the risk of potentially incorrect results from biotin interference could significantly affect patient or public health,” the guidance says. It also says ponsors should contact the appropriate CBER or CDRH review division if biotin interference at clinically relevant analyte and biotin concentrations in patient samples is demonstrated. And it recommends that studies designed to test for biotin interference follow designs similar to those included in the guidance entitled *Clinical Laboratory Standards Institute* *(CLSI) EP07, Interference Testing in Clinical Chemistry.*