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  • 1.  IDE filing and timelines for approval

    This message was posted by a user wishing to remain anonymous
    Posted 10 days ago
    This message was posted by a user wishing to remain anonymous

    Dear all,

    do you know how long usually the process of an IDE request takes to FDA and the IRB to grant the initiation of a pivotal clinical study for a class III device from the filing of the application, and how many round of questions/integration are allowed? 

    Looking forward to hearing your experience!



  • 2.  RE: IDE filing and timelines for approval

    Posted 9 days ago

    Hello Anon,

    You can get information concerning the IDE process here: https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-approval-process.  Basically an IDE is approved at Day 30 unless FDA notifies the Sponsor/Submitter of issues or concerns.  In my experience, FDA does notify the company within the 30 days majority of the time - but recommend using the Q-Submission process - note below.  There is also not really "rounds of questions" because an IDE is either Approved, Approve with Modifications, or Disapprove.  If there is a Disapproval notified, there is an opportunity for the Sponsor to provide additional information before the IDE is withdrawn.

    What this means is really utilise the Q-Submission process to discuss any challenging points in the clinical study protocol because it really can take a long time to get an IDE if the study keeps get disapproved.  The FDA reviewers are experienced in clinical trials, understanding the content, knowing clinical endpoints, good Case Report Forms (CRF), etc., so they are looking to ensure the clinical protocol meets criteria (review the IDE guidance document https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-decisions-investigational-device-exemption-clinical-investigations).  For the Institutional Review Board (IRB) this can depend on work load, board of the IRB, using a central IRB, etc., though usually a clinical trial protocol review and acceptance by an IRB is 2 to 3 weeks.



    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
    ------------------------------

    Original Message


  • 3.  RE: IDE filing and timelines for approval

    This message was posted by a user wishing to remain anonymous
    Posted 9 days ago
    This message was posted by a user wishing to remain anonymous

    I agree with Richard. It is 30 days. FDA can convert so you need another 30-day review, but that doesn't happen very often anymore. In a recent IDE I witnessed, the approval arrived right on the 30-day mark. There were multiple emailed questions that arrived when the subject matter expert at FDA was ready to send them with no specific cadence or separation of rounds.

    For a high-risk device, it's highly recommended to have those pre-sub discussions first. FDA could approve the IDE because the study is safe but that doesn't mean the protocol is sufficient to support your marketing claim. The pre-subs will help with that topic. 


    Original Message


  • 4.  RE: IDE filing and timelines for approval

    This message was posted by a user wishing to remain anonymous
    Posted 9 days ago
    This message was posted by a user wishing to remain anonymous

    I agree with everything Richard posted, but I wanted to add some addition information.  IDEs are approved/disapproved on the basis of safety - not if the study design will lead to the data collection necessary for a successful marketing application.  The FDA IDE review process is set at 30 days as a legal requirement so FDA must issue a decision in that timeline, whereas marketing applications are subject to MDUFA goals and we all know how those are goals - not requirements.  My experience with FDA is that if the 30 day clock is running out and they still have some concerns/questions around the sufficiency of data to support a marketing application, they'll give "Future considerations" in the IDE approval. Those future considerations may basically say, "you need to collect more data."  If the type of study or studies for the device are well established, it shouldn't be an issue to design the studies to get the data FDA needs.  If the device is novel and the methods of evaluating safety and effectiveness are not (or partially) established, pre-submissions are very helpful to get that feedback.  We also found that FDA cannot always answer what they'll need through pre-submissions. They can also just say, "put it in the IDE and we'll discuss."  Again, if the IDE 30-day clock runs down and those discussions aren't resolved, you may get "future considerations" in the IDE approval letter that are essentially leading you to do an IDE supplement (another 30 day clock) to address that feedback. 

    As for IRBs, for studies that are well established, the IRB should be able to review and approve in a relatively consistent time. For newer types of studies with entirely different protocols, expect them to take longer particularly if new questions of safety are involved. Most of the time IRB approvals for a standard study for a device I support are 3 weeks, but with a more novel design it's taking closer to 6 weeks. Timelines can get easily shifted if the initial IDE wasn't sufficient, making IDE supplements necessary, as you typically have to re-run those IDE supplement changes back through the IRB.


    Original Message


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