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  • 1.  Change after IDE approval

    This message was posted by a user wishing to remain anonymous
    Posted 24-May-2024 11:12
    This message was posted by a user wishing to remain anonymous

    Dear expert,

    I would like to hear your opinion on something I am reasoning about to shorten timelines about the initiation of an investigational study in US and in EU because there is a change of one component of the medical device that is planned. So, I was thinking to apply for the IDE and the different IRB in US, and the competent authorities in EU to obtain the approval to initiate the study with the current component. Then between the approval of the study and the actual beginning of the clinical use of the medical device on patients there will be probably a delay of about 3 months. By this time I will have all the validations of the new component available, so I was thinking to apply for a change of component in the investigational study before starting with the actual use of the device on the patient. Do you think is a sustainable and acceptable approach? any similar experience to share?

    Thanks!!



  • 2.  RE: Change after IDE approval

    Posted 25-May-2024 12:27

    Dear Anon - it would be helpful if you could clarify what the study protocol and application documents would say about the purpose of the study since it would appear from your proposal that you would write the protocol to study a cleared device? It seems that if you need to do an investigational study for the new component, the change is significant enough to represent a new risk for the device and that would require a full regulatory and ethical review for an amendment to the protocol?



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    Glen Park PharmD
    Consultant
    Burien WA
    United States
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  • 3.  RE: Change after IDE approval

    Posted 28-May-2024 04:55

    Hello Anon,

    The timing on what you want to do seems a little unclear because assuming you have an IDE approval, it may depend on what Amendment you are planning and type of change.  If you are going to change a component before getting IDE/IRB/Ethics Committee approval you should have all the testing done before.  However, there is nothing preventing what you may want to do, though there is regulatory risk associated with making a change, seeking approvals, and then waiting for testing to be done at some point later.  If you are going to make the change, recommend doing this and getting all testing done before seeking approval.  It does depend on the timing, but getting IDE/IRB approval before and then submitting an Amendment might be more challenging, then just waiting for the final device.  Plus making device component changes after IDE/IRB/EC approval may raise questions with the regulatory authorities why this is being done.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
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  • 4.  RE: Change after IDE approval

    Posted 28-May-2024 10:00

    Dear Anon,

    It sounds like you may be proposing a change to the investigational device after an initial IDE approval and before the initiation of the clinical study.  If that's the case, please note that the FDA guidance, Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff (fda.gov), would indicate that changes to the investigational device "not made in response to information from the investigation" would be an IDE Supplement. Since the clinical study wouldn't have started yet, the device change would appear to require an IDE Supplement.  IDE Supplements for device changes are 30-day reviews. It doesn't sound like you'd save any time on the FDA review as you'd essentially be "re-initiating" the IDE review. Both the initial IDE application submission and this type of IDE supplement are 30-day reviews.  It may be advantageous to still submit the IDE application with the initial version of the investigational device so you can move to IRB approval of the protocol and associated clinical documents. Then when ready with the new testing for the device change, submit the IDE supplement.  This strategy may result in an overall quicker clinical study readiness if you expect the device change wouldn't require the IRB to redo most of their review of the investigational study materials (i.e., little to no impact to protocol, device risk, etc).  I think FDA expects that sometimes sponsors are working through a few iterations of their investigational device, conducting concurrent series of tests to support the different iterations.  By the time the sponsor is ready to initiate a study, these tests may lead a sponsor to prefer a different iteration of the device than the specific device proposed in the initial IDE application. FDA will want the clinical data used in a marketing application to be collected using the final device, so as long as the devices are not drastically different in design from each other (e.g. different risk profile, entirely new set of testing because nothing previously submitted can be leveraged), I don't think FDA would raise concerns over the change as it just seems like the sponsor is honing in on the best iteration of the device for the clinical study. 



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    Katherine Doll Kanne
    Principal Regulatory Affairs Specialist
    Abbott
    Saint Paul MN
    United States
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  • 5.  RE: Change after IDE approval

    Posted 28-May-2024 15:52

    I agree with Katherine.  There could be some benefit to your overall timeline to get the regulatory authorities reviewing all your clinical related documents and any testing/information not impacted by the future change you have identified sooner rather than later.  Given your 3 month estimated time in between the initial approval and anticipated start ready date for the study, you may have enough time to submit the change and still (in the US) await the 30 day review time. 

    This all assumes, of course, that you don't get any significant questions from the reg authorities preventing you from obtaining the initial approval.  I tried something similar in the past and it blew up in our faces because FDA had substantial issues with some of the device testing in the original IDE and we were still working through those before I could bring up the design change with its associated testing.



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    Douglas Ferguson
    VP, Clinical and Regulatory
    Beta Bionics, Inc.
    Concord MA
    United States
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  • 6.  RE: Change after IDE approval

    Posted 28-May-2024 15:58

    Dear Anon,

    For the US (not EU): If your study is an Early Feasibility Study, you can use the Contingent Approval mechanism. To use this, you need to notify FDA of the device change & the test plan with acceptance criteria via Pre-Sub and/or the original IDE. Then you can report the data to FDA within 10 days of implementing the change as a Notice of IDE Change rather than going through another 30-day review. Even if your study is not an EFS, you could suggest this approach to FDA if you have an established history/relationship with the FDA review division / lead reviewer. I have used this mechanism successfully to manage study timelines. Good luck!



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    Hiral Dutia
    Manager, Regulatory Affairs
    Third Pole Therapeutics
    Waltham, MA
    USA
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  • 7.  RE: Change after IDE approval

    Posted 29-May-2024 06:19

    Hello,

    Everyone has given you very good advices here. All I can add is that I have seen companies doing this and it does not save time. At the end you still you need to wait for approval.

    It will be more cost-effective if you submit the modified device when you have all testing and obtain approval for it. 

    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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