GUIDANCE DOCUMENT
Testing for Biotin Interference in In Vitro Diagnostic Devices Guidance for Industry October 2020
- Docket Number:
- FDA-2019-D-1876
- Issued by:
-
Guidance Issuing OfficeCenter for Biologics Evaluation and ResearchCenter for Devices and Radiological Health
The Food the Drug Administration (FDA or we) is providing recommendations on the testing for interference by biotin on the performance of in vitro diagnostic devices (IVDs). This guidance is intended to help device developers and clinicians understand how FDA 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 apply to IVDs, including devices that are licensed under section 351 of the Public Health Service Act (42 U.S.C. 262) and used in donor screening, that use biotin technology. This guidance finalizes the draft guidance of the same title dated June 2019.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
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Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2019-D-1876.
Questions?
- Office of Communication, Outreach and Development (OCOD)
- Center for Biologics Evaluation and Research
Food and Drug Administration
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