Organization (Website) Origin: Federal Register (
https://www.federalregister.gov/)
Topic Brief:The below notice by the Food and Drug Administration was released on Friday 06/14/2019.
AGENCY:Food and Drug Administration, HHS.
ACTION:Notice of availability.
SUMMARY:The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Testing for Biotin Interference in In Vitro Diagnostic Devices; Draft Guidance for Industry." The draft guidance document provides FDA's recommendations on the testing for interference by biotin on the performance of in vitro diagnostic devices (IVDs). The draft guidance is intended to help device developers and clinicians understand how FDA recommends biotin interference testing should be performed and how the results of the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.
DATES:Submit either electronic or written comments on the draft guidance by August 13, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Visit the URL below for complete information on submitting comments and obtaining access to the Federal Register document.
URL: https://www.federalregister.gov/documents/2019/06/14/2019-12564/testing-for-biotin-interference-in-in-vitro-diagnostic-devices-draft-guidance-for-industry------------------------------
Lezlee Koch, ASCLS Patient Safety Committee
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