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  • 1.  Using a 510k cleared product for clinical studies

    This message was posted by a user wishing to remain anonymous
    Posted 26-Jan-2023 10:39
    This message was posted by a user wishing to remain anonymous

    We are using our 510k cleared Biomarker testing kit for CDx clinical studies. Should I label the kit as IUO or IVD?


  • 2.  RE: Using a 510k cleared product for clinical studies

    Posted 26-Jan-2023 11:04
    More details may be needed to assure proper advice for your particular scenario.  But as a general rule, if a 510k-cleared device is being used for its 510(k)-cleared intended use and indications, then it is to be labeled in accordance with its 510(k)-cleared labeling.  Yet, if a Sponsor instead uses its 510(k)-cleared device outside of the device's 510(k)-cleared intended use and indications, then, the 510(k)-cleared labeling would no longer be representative of the device's use, thus causing the need for revisions, such as IUO in a clinical study of that device.  Whether a 510(k)-cleared device is used for its 510(k)-cleared use within a clinical study of a different device, or for any other 510(k)-cleared use, is generally moot with respect to the 510(k)-cleared device's labeling.

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    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


  • 3.  RE: Using a 510k cleared product for clinical studies

    Posted 26-Jan-2023 11:05
    Hi, IVD /IUO Will depend on the intended use of the FDA cleared device when it comes to use in clinical studies.
    if it is planned to be used in accordance with the labeling cleared by FDA, it can be labelled IVD. 
    if it is planned to be used in clinical study (off‑label use) other than what is intended on FDA cleared label of the cleared device, it is IUO.
    hope this helps.



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    RAJE DEVANATHAN
    Senior Manager
    Oakville ON
    Canada
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    Original Message


  • 4.  RE: Using a 510k cleared product for clinical studies

    Posted 27-Jan-2023 10:36
    Hi,
    Is the 510K cleared kit approved for the marker as a CDx (I am assuming not)? Then it should be labeled IUO.
    One more thought: are you sure the use of the kit in the study is considered non significant risk? If not you may need an IDE.

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    Sarah Parsons RAC
    Principle Northcoast Consulting
    Regulatory Affairs, Diagnostics
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    Original Message


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