Regulatory Open Forum

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  • 1.  Pediatric Clearance

    Posted 06-Jun-2013 13:48
    Does anyone have experience in obtaining clearance for a 510(k) cleared product to market in a sub-population i.e. pediatrics without having to go through clinical trials? If yes, could you please share your experience?


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    Vishal Kanani
    Stryker
    Kalamazoo MI
    United States
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  • 2.  RE: Pediatric Clearance

    Posted 01-Jun-2017 18:06
    Also interested.  This was posted a few years ago, prior to FDA guidance regarding leveraging adult data for Peds.  Wondering how others have managed to obtain Peds indications.

    Thank you!

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    Gretchen Upton RAC
    RA/QA
    Helotes TX
    United States
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    Original Message


  • 3.  RE: Pediatric Clearance

    Posted 01-Jun-2017 19:35
    Vishal,
    As a reviewer I participated in several reviews where projects were 510(k) cleared without clinical evidence for pediatrics. Depending on the device type, this can be straight forward or an enormous pain. A clinical evaluation (not necessarily data) should be submitted for the consideration of the pediatric population. Some things to consider will be technical design for the anatomy of peds, biocomp/tox considerations for younger patients, and the effects of growth and development. A strong justification should be submitted and I would consider submitting independent assessments from pediatric clinicians in the field.

    Feel free to message me if you'd like more information,

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    Michael Nilo
    Network Regulatory Partners
    Nilo Medical Consulting Group
    Portland OR
    United States
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    Original Message


  • 4.  RE: Pediatric Clearance

    Posted 05-Jun-2017 15:43
    Edited by Elizabeth Goldstein 05-Jun-2017 15:44

    Hi Vishal,

    I've listed some of my considerations for determining a submission plan below – some - the V&V plan will probably also give you a good indication of which path you're headed down.

    • What is/are the patient population(s) for your predicate device? Does it include the patient population that you want to gain clearance for?
      • If not, are there other predicate devices which might be a more suitable option?
    • Based on published 510(k) summaries, what kind of evidence has been used to support 510(k)s for recently cleared similar devices? Even though it doesn't guarantee anything, the summaries might give you a good indication of current practice.
    • Are there any product standards, guidance documents, etc. which specify performance requirements specific to your patient population? This might be a long shot, but I have seen some performance standards that differentiate requirements for different populations.  If this is the case, you might have a good argument for demonstrating safety and effectiveness using bench testing.
    • What are the anatomical differences/similarities for you proposed patient population compared with currently treated populations? (I think this links in with Gretchen's comment regarding leveraging adult data for pediatrics, although I haven't read the specific guidance documents that she has referenced.)  If your device is intended to interact with/treat a part of the anatomy that develops at an earlier age, then you might be able to make a good argument that clinical data on the proposed population is not required.

    Depending on how much time you have and how comfortable you are with your strategy, a pre-submission is never a bad idea.  It will give you a chance to get feedback on your submission strategy, including proposed testing/evidence, and get some input without worrying about review timelines, questions, etc.  It will also help you develop a more robust strategy, e.g. does the team need to factor additional timing into the development plan?

    I think some of this is quite general, but I hope that it is valuable!

    -Liz



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    Elizabeth Goldstein RAC
    Regulatory Affairs Specialist
    Medtronic Vascular
    Santa Rosa CA
    United States
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    Original Message