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New 21 CFR 892.2060

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  • New 21 CFR 892.2060

    Hi Folks!

    The FDA granted a DeNovo Medical Device (DEN170022), with the following Reclassification Order:

    On this occasion, a new section was created:
    21 CFR 892.2060, defining

    "Radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer. A radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer is an image processing device intended to aid in the characterization of lesions as suspicious for cancer identified on acquired medical images such as magnetic resonance, mammography, radiography, or computed tomography. The device characterizes lesions based on features or information extracted from the images and provides information about the lesion(s) to the user. Diagnostic and patient management decisions are made by the clinical user."

    This section is not updated on LII website yet (nor in the e-CFR, see

    Quentin de Snoeck

  • #2
    Thanks for your note. The DeNovo letter that you link to includes the following sentence:
    A notice announcing this classification order will be published in the Federal Register.
    A quick search on for items affecting 21 CFR Part 892 reveals that no such notice has been posted since the July 2017 letter you link to. Because the notice has yet to be published in the Federal Register, it makes sense that the information is not available in the CFR.

    For information about our particular CFR collection and how it is updated, please see our post on "How current is the information on the LII website, which says,
    We update our collections of the US Code and Code of Federal Regulations (CFR) each time the government releases a new machine-readable version. Each page of these two large primary law collections contains a yellow box indicating the most recent public laws (which can either be new laws or changes to existing ones) included in the latest electronic update. Anything newer than that will not yet appear in our collection.