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FDA Issues Draft Recommendations for Biotin Interference Testing

The US Food and Drug Administration has issued draft guidance that provides recommendations on testing for biotin interference with in vitro diagnostic devices.

Today's draft guidance, building on a safety communication that the agency issued in 2017, provides additional recommendations to IVD manufacturers about testing for biotin interference as well as recommendations about communicating the results of such testing to users of diagnostic tests.

The FDA said that it will continue its work with stakeholders to better understand biotin interference with laboratory tests, including working with manufacturers as they address the issue in designing and developing tests that use biotin technology.


INDUSTRY NEWS TAGS: Genomics


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