Regulatory Open Forum

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  • 1.  software changes after CT

    This message was posted by a user wishing to remain anonymous
    Posted 13 days ago
    This message was posted by a user wishing to remain anonymous

    Hi,

    We're about to do a CT , however there are some software changes including those related to non-device functions which are expected post the CT before the submission. What kind of changes are allowed without  having to redo the CT?



  • 2.  RE: software changes after CT

    Posted 12 days ago

    What do you mean about to do a CT - what is a CT?



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
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  • 3.  RE: software changes after CT

    Posted 12 days ago

    Hello,

    I am assuming that by 'CT' you mean clinical trial? If this is correct then you are asking what you should do if there are changes in the software after the clinical trial is approved and ongoing. In such case you need to submit the software changes as amendment for approval to the regulatory agency. 

    Good luck with your study.

    Olga



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    Olga Peycheva
    Regulatory and Study Start Up Specialist (Clinical trials)
    Solutions OP Ltd
    https://solutionsop.co.uk/
    United Kingdom
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  • 4.  RE: software changes after CT

    Posted 12 days ago

    Hi Anon

    There isn't really a rule - it's more a matter of rationale, justification, and judgment.

    When you prepare a device submission for approval, you'll have a variety of supporting evidence for safety and effectiveness, and you can explain what is relevant and why. If you're not changing the core clinical algorithms, then you can use the old clinical trial as evidence that the algorithm works. If you're changing the user interface, you can do a new usability validation to cover those aspects without redoing the clinical trial.

    I'm not aware of any jurisdictions absolutely requiring a full CT on the final version



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    Anne LeBlanc
    United States
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