Regulatory Open Forum

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  • 1.  IDE design control requirement for modifying off the shelf software

    Posted 13-Oct-2017 10:57
    I am a rookie Regulatory Specialist requesting advice on the applicability of design control regulations for an IDE to test modification to the software (via firmware update) of an approved device.  I note that for an IDE, QS regulations are exempted, but design control requirements apply.  I am confused by the Guidance which states, "The design control requirements are basic controls needed to ensure that the device being designed will perform as intended when produced for commercial distribution. Clinical evaluation is an important aspect of the design verification and validation process during the design and development of the device. Since most of the device design occurs prior to and during the IDE stage, it is necessary that manufacturers who intend to commercially produce the device follow design control procedures."  The IDE is not intended to support commercial distribution, and the Investigator is not the manufacturer.  Is the investigator researching the firmware update subject to the design control requirements, and if so, where is that included in an IDE?  This forum's advice is much appreciated.

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    SheilaAustin
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  • 2.  RE: IDE design control requirement for modifying off the shelf software

    Posted 14-Oct-2017 11:01

    This really depends on why there is an investigation; what is the investigational device? Presumably, there is some device under investigation for which there is an intention to bring that device to market. That is the device subject to design control. Before the investigational device got to the Investigator, the manufacturer should have implemented design controls. Not all aspects are necessarily complete. For example, design validation may require information from the trial; design transfer is not complete (but a reasonable portion applied to the product in the trial).

     

    If the device with software is being modified for use in the trial, but is not the investigational device, then, in my opinion, design controls do not apply, from the regulatory sense. However, if the modified device is used in the course of the trial, there should be detailed records of its configuration. One method is use design controls as a framework. In particular, I recommend design inputs, design outputs, design verification, and design validation as applied to the software. In addition, whoever is modifying the device should follow the FDA-CDRH guidance document on software.

     

    The potential problem is failure to keep good records of the device modification may call into question the results of the investigation. An ounce of prevention is worth a pound of cure.



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    Dan O'Leary
    Swanzey NH
    United States
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  • 3.  RE: IDE design control requirement for modifying off the shelf software

    Posted 14-Oct-2017 14:44

    Hi Sheila,

    I agree with Dan's points. Also wanted to share the "Changes or Modifications During the Conduct of a Clinical Investigation" FDA Guidance document, if you haven't found it yet. This describes how changes to a device under investigation should be assessed, documented and reported to FDA if needed.  

    https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm082158.pdf

    I would ask if your clinical study protocol include direction on how to handle changes to a device under investigation? If not, perhaps the IDE Sponsor has a procedure in place for how to assess, document and implement changes. If it is the Investigator that wants to modify the investigational device, I would think you need to review these changes with the IDE Sponsor/Manufacturer and document them per their procedures.

    I'm not completely clear on your situation, but think I experienced a similar issue during a clinical study. The devices under investigation were deployed at a clinical site and we wanted to update the software to resolve a network connectivity bug. This issue was unrelated to the safety and effectiveness of the product and would have no impact on the outcome of the study. We had included guidance in our clinical study plan for how changes to the device during the clinical study would be handled. We used a service report to document the changes made and our assessment of the impact on the device. In the final clinical study report, we referenced this service report and included it as an attachment. 

    Tying this back to design controls – you would want to assess if the software modification has any impact on existing design inputs, design outputs and verification/validation. I would think you would again need to consult with the IDE Sponsor/Manufacturer to complete this assessment.  



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    Lindsey Folio RAC
    Regulatory Affairs Consultant
    Network Partners
    Beaverton OR
    United States
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  • 4.  RE: IDE design control requirement for modifying off the shelf software

    Posted 16-Oct-2017 08:41
    ​Thanks for the advice.  I am at an academic institution and the investigator is a sponsor-investigator.  I want to make sure I am not missing important detail for the FDA to review the IDE (relative to the software update that is the subject of the investigation) as the investigator does not want to pursue a pre-sub for the IDE.  The marketed device that will be used in the trial is being used according to the approved indication.

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    SheilaAustin
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  • 5.  RE: IDE design control requirement for modifying off the shelf software

    Posted 17-Oct-2017 22:32
    Hi Sheila,

    Another webpage that may be helpful for you is at the link below, particularly the IDE Exempt Investigations section.  If you are using the device in accordance with its already cleared or approved indications for use and labeling, an IDE is not required. Without knowing all the details, it sounds like this may be the case for you.  I'd read through this section in more detail.  

    IDE Approval Process

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    Lindsey Folio RAC
    Regulatory Affairs Consultant
    Network Regulatory Partners
    Beaverton OR
    United States
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