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  • 1.  Features not cleared for SaMD

    Posted 27-Jun-2022 11:56

    Hi,

    I am writing a 510k for a stand alone software. If I wanted to enable a certain feature of the device as part of a clinical trial but not have that part of my 510k (I will be writing a future submission for it), can I write a disclaimer saying this feature isn't cleared by the FDA and still display the feature? 



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    Rania deLeon
    QA & RA Manager
    Morton PA
    United States
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  • 2.  RE: Features not cleared for SaMD

    Posted 28-Jun-2022 10:16
    Hi there,

    As part of the About screen for the clinical trial/non-released software, add 'CAUTION - Investigational device. Limited by Federal (or United States) law to investigational use.'

    Hope that helps!


    -Savannah

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    Savannah Hari
    Victoria BC
    Canada
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    Original Message


  • 3.  RE: Features not cleared for SaMD

    Posted 28-Jun-2022 10:47
    Hi Savannah,

    Thanks for your response! The software itself will be (hopefully) 510k cleared, but there will be a feature that won't be cleared until a future submission. Can I say that specific feature is for a clinical trial?

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    Rania deLeon
    QA & RA Manager
    Morton PA
    United States
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    Original Message


  • 4.  RE: Features not cleared for SaMD

    Posted 28-Jun-2022 12:35
    Hello Rania,

    Without fully understanding the Software as a Medical Device (SaMD) how it is used, menu flow-through, and how the user interacts, could only provide limited thoughts.  If a software application has multiple features, the best way is to "lock out" the features which would be part of the clinical trial which requires accessing these features through a different log-in or different module.  It may be acceptable to have an "Accept" pop-up window when they access a feature with full disclaimer as Savannah noted the investigation device terms used by the US FDA.  However, when a customer is using a cleared device (SaMD) as intended, there needs to be a way they should not be able to use the investigational part during normal use and operation.  Based on the software application, use a risk-based approach on how the clinical trial feature is limited or can only be used for the clinical trial.  Yes, this can be complicated with software applications because turning on and off features might be difficult or even not possible.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 5.  RE: Features not cleared for SaMD

    Posted 28-Jun-2022 14:05
    Thank you for the responses! This is helpful.

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    Rania deLeon
    QA & RA Manager
    Morton PA
    United States
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    Original Message


  • 6.  RE: Features not cleared for SaMD

    Posted 05-Jul-2022 01:31
    Hello Rania,
    Here is the name of the FDA guidance about Softwear:

    Deciding When to Submit a 510(k) for a Software Change to an Existing Device 



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    Yana Dutt-Singkh
    Dr
    Mountain View CA
    United States
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    Original Message


  • 7.  RE: Features not cleared for SaMD

    Posted 29-Jun-2022 09:47
    Hello Savannah,
    does this message will not create a confusion and indicate that the device is under IDE submission?

    once an IDE application is approved, the following requirements must be met in order to conduct the investigation in compliance with the IDE regulations:

    • Labeling - The device must be labeled in accordance with the labeling provisions of the IDE regulations (§812.5) and must bear the statement "CAUTION - Investigational Device. Limited by Federal (or United States) law to investigational use."
    My understanding is that, in this case, this the future function of the device that will be available, but not under clinical investigation as FDA would expect when this sentence is present.



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    Stephane Berger
    La Ciotat
    France
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    Original Message


  • 8.  RE: Features not cleared for SaMD

    Posted 04-Jul-2022 07:46

    Hi Rania, 

    What you want to achieve (ideally) is segregation in such a way that users on the cleared device are unable to access investigational aspects. Feature toggling may or may not have been engineered for your product. One solution is to have separate Environments for investigational and cleared aspects of the device - it does allow for a cleaner way to maintain software in such situations. Ultimately, the risk of allowing use of an uncleared device maybe too great depending on what the actual feature is. 

    Thanks,



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    Richie Christian
    Head of Quality and Regulatory
    Auckland
    New Zealand
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    Original Message


  • 9.  RE: Features not cleared for SaMD

    Posted 05-Jul-2022 01:22
    Dear Rania,
    In my experience for the additional features, if they are not impacting the results of the whole device and not introducing additional risk to a patient,  we have submitted a Special 510 K.
    However, the extended risk analysis comparing the cleared feature vs additional new feature should be provided to the agency to demonstrate the absence of negative impact on the results. 

    If the new feature is  just a part of the manufacturing  life cycle of the product , but not a final production equivalent, then it goes through the normal process of change and development until the last version will not be made and generate data for  the regulatory approval.

    In addition, FDA provided a separate guideline for the SW and how to proceed with the changes .


    Thanks,
    Yana Dutt-Singkh, MD, MSHS

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    Yana Dutt-Singkh
    Dr
    Mountain View CA
    United States
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    Original Message


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