Regulatory Open Forum

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  • 1.  Unapproved medical device in a clinical trial

    Posted 22-Mar-2021 12:25
    When using an unapproved medical device in a clinical trial what do I need to consider? The trial would not seek approval of device use but the device (a blister producer for liquid extraction and analysis) would be used to obtain a liquid specimen for analysis. Needless to say, safety and side effects would be collected and regulatory authority approval would be obtained.

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    Sandra Sinclair
    Director, Clinical Operations
    Santa Fe TX
    United States
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  • 2.  RE: Unapproved medical device in a clinical trial

    Posted 23-Mar-2021 09:09
    Hello Sandra,

    I would say any medical device in a clinical trial needs to be assessed by the Ethics Committee/Institutional Review Board for how the product is being used and included in the clinical trial protocol.  It does not really matter if the clinical trial is being used for approve the device or some other purpose, any non-approved device used with human subjects should be reviewed by Ethics Committee/IRB.  If the subject device is being used ancillary to main clinical protocol needs, it might just need to be identified.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Unapproved medical device in a clinical trial

    Posted 25-Mar-2021 09:56
    Hi Sandra,  

    All clinical evaluations utilizing investigational devices, unless exempt, must have an approved IDE before the study is initiated. There are basically 3 classifications you can refer to : 1) a study with a device that carries significant risk 2) a study with a device that carries non-significant risk and 3) studies where IDE exemption has been claimed.  These website should be most helpful:

     https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-approval-process

    https://www.fda.gov/medical-devices/investigational-device-exemption-ide/clinical-trials-and-ide-guidance-documents

    And to Richard's point, regardless the pathway, the study must obtain an IRB/Ethics Committee approval before.  

    Feel free to reach out if you have additional questions.

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    Belinda Larson
    Wyoming MN
    United States
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    Original Message


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