Regulatory Open Forum

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  • 1.  Voluntary early termination of an IDE

    Posted 18-Dec-2014 05:13
    HI everyone,

    I'm hoping someone will be able to provide guidance. One of my clients is a sponsor of an IDE. They are three years into the trial and have recently decided to no longer pursue the PMA for their device. As a result, the sponsor would like to terminate the trial. The thing is however, there's no guidance or information in the IDE regs that specifically relate to voluntary early termination of an IDE. I'm sure a sponsor terminated IDE isn't uncommon and am hoping someone may be able to shed light on this for me.

    Thanks in advance,


    Mark Paquin
    Miami Beach FL
    United States

  • 2.  RE: Voluntary early termination of an IDE

    Posted 18-Dec-2014 10:58

    A medical device trial can be discontinued by sponsor or due to withdrawal of FDA or IRB approval.

    Whether it is due to "unanticipated adverse device effect" or "business reasons" or else, it is generally stated as "voluntary withdrawal." 

    Before your sponsor proceeds with termination, there are points of consideration including participants' complaint.

    I would suggest your client communicate with the FDA.

    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR
    Phone (Toll-Free): 1-(800) 321-8567
    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

  • 3.  RE: Voluntary early termination of an IDE

    Posted 19-Dec-2014 07:22
    Thanks, David! This what I thought as well, but wanted to double check. I'm sure there will be some reporting and record maintenance requirement that will be required, aside from what's outlined in the regs. That will be negotiated between my client and the FDA. Again, thank you and happy holidays. 

    Mark Paquin
    Medical Products Marketing Consulting, Inc.
    Miami Beach FL
    United States

  • 4.  RE: Voluntary early termination of an IDE

    Posted 19-Dec-2014 12:12
    Hi Mark -

    I've closed out two IDEs as you describe.  The first thing I had to do was do a closing visit to each participant site for a final monitoring visit and to collect any outstanding data - you can inform the site then about the closure, or you can wait until after you have notified the FDA.  Once I had all of the outstanding data entered, I compiled a report (it happened to be the annual report, for us) summarizing all of the data and submitted it to FDA.  You can describe your reasons for closing the IDE in the cover letter.  Depending on the state of the IDE and the required patient follow-up, FDA may require that you continue to follow all enrolled patients through to the end of the originally designated follow-up period.  If you want definitive guidance prior to moving forward, as David recommended, you can contact FDA.

    I hope this is helpful!

    Laurie Cartwright
    Senior Manager II, Regulatory Affairs
    Smith & Nephew (formerly ArthroCare Corporation)
    Irvine CA
    United States

  • 5.  RE: Voluntary early termination of an IDE

    Posted 19-Dec-2014 21:25
    I think the lack of specific guidance is because there isn't much to say beyond what is already in the regulations: 

    812.40 General responsibilities of sponsors

    ...ensuring that any reviewing IRB and FDA are promptly informed of significant new information about an investigation.

    The fact that the sponsor is terminating the investigation meets the criteria of "significant new information" about the investigation.

    812.150 Reports

    (7) Final report. In the case of a significant risk device, the sponsor shall notify FDA within 30 working days of the completion or termination of the investigation and shall submit a final report to FDA and all reviewing the IRB's and participating investigators within 6 months after completion or termination. In the case of a device that is not a significant risk device, the sponsor shall submit a final report to all reviewing IRB's within 6 months after termination or completion.

    Once the FDA receives notification under 812.40, they may ask for specific information to be included in the final report that is to be submitted under 812.150.  The IRB may have some specific requests also.

    David refers to "voluntary withdrawal."  This refers to the IDE.  The IDE may need to be left open until the final report on the investigation has been submitted; otherwise, the final report may have no place to go administratively.  I'd just submit the notification of termination and then wait for FDA to respond before trying to withdraw the IDE.  They might do that automatically upon receipt of the final report.

    I can't think of any reason the sponsor can't tell investigators to stop enrollment as soon as the decision is made to terminate the study, but I would not make any changes in how patients who are currently enrolled in the study are treated and/or followed until I heard back from the IRB and FDA.  The premature suspension of treatment per the approved protocol can sometimes be medically unwise; the investigators can probably advise the sponsor regarding whether this is likely to be a concern.  Follow-up often serves to monitor the welfare of patients who have been exposed to an unapproved device; the need for that doesn't necessarily go away simply because the sponsor has decided not to enroll any more patients.

    I would address these issues in the notification to both the IRB and the FDA.  If you don't think it post any risks to enrolled patients to discontinue treatment or follow-up, I suggest that you state your intention to do this in the notification, and include the justification.

    Julie Omohundro RAC
    Durham NC
    United States