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  • 1.  software in pre-clinical study: does it require IDE?

    This message was posted by a user wishing to remain anonymous
    Posted 12-Feb-2024 16:16
    This message was posted by a user wishing to remain anonymous


    Our office is engaging a manufacturer of a software that has its own 510K with FDA. Their product has evolved over the years and now they are planning to submit a new 510K. Meanwhile, we are thinking to launch a product that is in between the cleared and the new version, Both offices want to do this to collect some retrospective clinical data within the US using the software. In this case, I wonder if we still need to ask them to file IDE, or is it ok because it's not a clinical trial (rather, a data validation?) 

    Thank you in advance.

  • 2.  RE: software in pre-clinical study: does it require IDE?

    Posted 13-Feb-2024 04:26

    Hello Anon,

    First, an Investigational Device Exemption (IDE) submission would only be required if the device and/or software application would be considered Significant Risk (SR).  A Non-Significant Risk (NSR) device would not need an IDE.  The first step would be determining if the device and/or software is considered SR or NSR - feedback can be requested from the US FDA or an Institutional Review Board (IRB).

    The question regarding whether the software and/or device would need to be considered a clinical trial is depending on what it is being used for, how the data is being provided, and interaction with the patient.  Any human subject interaction whether this is directly with the patient or indirectly such as results from the software being provided for diagnosis or other aspects (monitoring) would need a clinical trial.  The question whether it would be a data validation or clinical trial depends on the software application, how the data is analysed, how data is going to be reported, and how data is going to be used.  If this is using retrospective clinical data all being done internally to the company, then most likely it would be a type of validation.  More information would be needed to provide a succinct answer.

    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant

  • 3.  RE: software in pre-clinical study: does it require IDE?

    Posted 13-Feb-2024 09:55

    This very much depends on the details. If the "interim release" has been assessed for the need to file a new 510(k) and has been documented as not requiring one, then no IDE is needed, because it is covered under the cleared product.

    If, however, the assessment determined a new 510(k) IS needed for this "interim" release, then yes, the IDE regulations apply. Even then, it is possible the study could be considered a "non-significant risk" - this should be assessed separately. Note that even if it is NSR, the IRB at your clinical site needs to agree.

    It's also possible that your "study" doesn't meet the definition of a clinical study to which the IDE regulation applies. This is commonly (but not always) true for human factors studies that do not involve patients, treatments or diagnoses. In this case, no IDE would be needed to do this activity as part of your V&V activity.

    I encourage you to clearly assess the status of the study, and also to assess the regulatory status of the interim release according to the many FDA guidances out there.


    Ginger Glaser RAC
    Chief Technology Officer

  • 4.  RE: software in pre-clinical study: does it require IDE?

    Posted 13-Feb-2024 12:12

    A key to determining the applicability of Part 812's IDE requirements is whether the planned study is a clinical "investigation" [812.3(h)].  Specifically, this means a clinical investigation or research involving one or more subjects to determine the safety or effectiveness of a device.  Whether clinical data from those subjects are incorporated retrospectively (such as via EHR or RWD) or prospectively, Part 812 still generally applies if the study is a clinical investigation.

    Also, be sure to remember that an approved IDE is always required for non-exempt studies regardless of whether the study is SR or NSR.  Be careful not to confuse or equate this requirement with the separate requirement (or lack thereof) for submitting an IDE application (required for SR, but not for NSR) to gain the always-required IDE approval.

    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
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