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  • 1.  Nonsignificant risk device designation

    Posted 19-Jan-2017 09:59

    I am looking for some guidance on whether there is additional documentation or approval needed for a needle free injection device to be used in an upcoming trial. A DMF for the device was filed previously. Would it be sufficient to refer simply to that DMF or is there some additional step needed in order to include the device in a US clinical trial? The supplier suggested this "nonsignificant risk" designation but I am not sure what exactly that means. Would including this unapproved device (no 510k) add time to the IND review?

     

    Thanks,

    Martha

    Cambridge, MA 



  • 2.  RE: Nonsignificant risk device designation

    Posted 19-Jan-2017 12:31
    If the device is not legally marketed in the US for an intended use that is consistent with its use in the trial, you will need to have an IDE.  If an IRB determines (in writing, so it really happened) that the device is not a significant risk device as defined under 21 CFR 812.3, then you will not need to submit an IDE application to FDA, as long as you meet all of the requirements for an abbreviated IDE identified in 21 CFR 812.2(b)(1).

    There is an information sheet on the topic, which helps some and confuses some because it talks in terms of non-significant risk device studies rather than non-significant risk devices:

    http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.pdf


    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 3.  RE: Nonsignificant risk device designation

    Posted 24-Jan-2017 04:20
    Julie is right on this one and FDA sometimes forgets if it is on label it shouldn't require an IDE because on label use is a non-significant risk use.  We have had to debate this with the Agency more than a few times.  The problem is that with a drug delivery device you have a combination product and you have both IND and IDE regulations to consider and the complications of whether the use of a specific drug in the device is rightfully on label or off.

    Mark DuVal  



    Sent from my Verizon, Samsung Galaxy smartphone



    Original Message


  • 4.  RE: Nonsignificant risk device designation

    Posted 25-Jan-2017 09:02
    Thanks to all for your input. This has been very helpful.

    Best,

    ------------------------------
    Martha
    ------------------------------

    Original Message


  • 5.  RE: Nonsignificant risk device designation

    Posted 20-Jan-2017 09:52
    Martha,

    From your e-mail I assume you are testing a drug for initial approval or an existing drug for delivery needle free.  Either way, FDA has recently indicated that needle free delivery is a different route of administration than SubQ or IM (with a needle).  This study will be completed under an IND, with reference to the needle free Master file and data showing compatibility and performance with your drug in the IND.  No IDE is required and device study risk (significant or not) is irrelavent.

    You might want to consider that this is likely a Combination Product and will have other elements and compliance requirements. 

    The review period for an IND is still 30 days, but yes, this will complicate the review and may end up in some sort of clinical hold if your submission or the device master file is incomplete..

    Lee

    ------------------------------
    Lee Leichter RAC
    President
    P/L Biomedical
    Fort Myers FL
    United States
    ------------------------------

    Original Message


  • 6.  RE: Nonsignificant risk device designation

    Posted 20-Jan-2017 11:39
    If you are a hammer, everything's a nail.  I'm device oriented; I would pursue it via IDE, but if it can be folded into an IND, that works for me too.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


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