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FDA releases final guidance on Applying Human Factors and Usability Engineering to Medical Devices

Discussion in 'US Medical Device Regulations' started by Ronen E, Feb 5, 2016.

  1. Ronen E

    Ronen E Well-Known Member

    Jul 31, 2015
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    Document issued on: February 3, 2016

    As of April 3, 2016, this document supersedes “Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management” issued July 18, 2000.

    The draft of this document was issued on June 21, 2011.

    The FDA has simultaneously issued, as draft guidance, the "List of Highest Priority Devices for Human Factors Review"
    yodon likes this.