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  • 1.  Abbreviated IDE

    This message was posted by a user wishing to remain anonymous
    Posted 12-Oct-2021 16:54
    This message was posted by a user wishing to remain anonymous

    We currently have a protocol for a non-significant risk device that the sponsor-investigator would like to commercialize and bring to market pending the results of the study and if it is found to be effective.  They already have a patent pending on the product.  They haven't initiated the study yet.  I believe this would fall under the category of an abbreviated IDE but have never submitted one in my career.  Would an abbreviated IDE be submitted to the FDA like a full IDE?


  • 2.  RE: Abbreviated IDE

    Posted 13-Oct-2021 07:40

     

     

     

    Hi Anon,

     

    Good question.  The gatekeeper(s) for NSR studies are the IRB(s) overseeing the study, so an IDE application to FDA is only required if an IRB disagrees with your conclusion that the study is NSR.  Otherwise, IDE requirements are pretty limited; specifically, the seven items listed in 812.2(b)(1) apply.

     

    You could consider sending FDA a rationale for your NSR conclusion to seek their concurrence before submitting to IRBs, or else just have it ready in case an IRB disagrees.  You may also want to include that rationale with IRB packets.

     

    Best regards,

     

    Ted

     

    --

    Theodore (Ted) Heise, PHD, RAC

    Vice President Regulatory and Clinical Services

     

    MED Institute Inc.

    1330 Win Hentschel Blvd.

    West Lafayette, IN  47906-4149 USA

    765.463.1633 ext. 4444

    http://medinstitute.com

    theise@medinstitute.com

     




    Original Message


  • 3.  RE: Abbreviated IDE

    Posted 13-Oct-2021 09:09

    Ensure you have read through the FDA's IDE Approval Process webpage:

     https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-approval-process

     

    Then, I suggest reading through this guidance to be sure you understand the connection to what you'll need to send to your Institutional Review Board (IRB) as they will want to see your rationale for the study being a nonsignificant risk (NSR) study.

     FDA Guidance Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors Significant Risk and Nonsignificant Risk Medical Device Studies

    https://www.fda.gov/media/75459/download

     

    If the IRB agrees with the NSR determination, then the 'abbreviated IDE' content is all the records that the manufacturer (you) need to keep in support of the study and the safety of the participants. The IRB will want to see, at minimum, the labeling, and the informed consent. It's best to work with them to agree upon the content as different IRB's can require different content. Also, I've seen some IRB's not support NSR studies without some interaction with FDA to agree that the study is indeed NSR.



    ------------------------------
    Isabel McGann MS, RAC
    Regulatory Program Manager
    Westminster, CO
    United States
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    Original Message


  • 4.  RE: Abbreviated IDE

    Posted 13-Oct-2021 11:08
    Whether the study is significant risk (SR) or non-significant risk (NSR) depends on the protocol and the review by either an IRB or CDRH which determines if the study is non-significant risk.  Having an internal review of the protocol risk is very helpful in positioning the study as SR or NSR for the protocol and respective review bodies.  Regarding an abbreviated IDE for an NSR, an IDE submission is not required.  It is considered to have an approved IDE without having to submit an IDE; however, abbreviated requirements apply (see list below):
    • Labeled as an investigational device
    • IRB approval required
    • Informed consent obtained from each patient
    • Compliance with monitoring requirements
    • Maintenance of proper records and reporting
    • Not promoted or sold



    ------------------------------
    Julie Engel
    Regulatory Program Manager, Companion Diagnostics
    Jacksonville FL
    United States
    ------------------------------

    Original Message


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