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  • 1.  recommended procedure before submission 510(k)

    Posted 22-Aug-2019 08:56
    Dears 

    quick question. If I am ready and prepared Tech file for FDA 510(k) submission, do you recomend me to manage initial meeting with the FDA authority, talk with them before the submission? Is there any recommended procedure?

    thank you very much

    Best Regards

    Lukas Peter

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    Lukas Peter
    Ph.D.
    Ostrava
    Czech Republic
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  • 2.  RE: recommended procedure before submission 510(k)

    Posted 23-Aug-2019 05:34
    Lukas,

    You would have to provide more information about what type of device and why you would want to have an initial meeting with FDA.  The Q-Submission process can be used a number of ways for obtaining feedback from the FDA.  If you are unsure about the Product Code, indications for use statement, performance testing, bench performance testing, clinical studies required, clinical study protocol, etc., then an initial meeting with FDA might be helpful.  If you have unresolved questions relating to what you believe should be in the 510(k) submission such as performance data or clinical data, the Q-Submission process is an excellent way to get feedback to understand what would be expected.  With that said, if you do not have any unresolved issues and believe your 510(k) submission is sufficient, then you should be able to submit.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: recommended procedure before submission 510(k)

    Posted 23-Aug-2019 07:28
    Lukas,

    Your question is rather open-ended, as there is no need to schedule a meeting or discussion with FDA if your submission is straightforward (well-defined predicate, consensus standards, etc.).  However, if there are issues about predicate device, deviations from standards, anything that might raise a question from FDA, then at least a communication would be in order to assess FDA's expectations.  An actual meeting would probably not be required for a 510(k) submission.

    James

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    James Bonds J.D.
    Director Regulatory Affairs
    Atlanta GA
    United States
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    Original Message


  • 4.  RE: recommended procedure before submission 510(k)

    Posted 23-Aug-2019 08:12
    Lukas,

    I don't remember ever seeing anything referred to as a Tech File for a 510<gwmw class="ginger-module-highlighter-mistake-type-3" id="gwmw-15665620628813979476568">(</gwmw>k) submission. I highly suggest you use the format suggested by the FDA and include the checklist (use the appropriate checklist for the type submission you are making). See link below.

    Acceptance Checklists for 510<gwmw class="ginger-module-highlighter-mistake-type-3" id="gwmw-15665621597148110705243">(</gwmw>k<gwmw class="ginger-module-highlighter-mistake-type-3" id="gwmw-15665621597148074429297">)</gwmw>s

    If you have questions, email to me at rbard@reglaw.net.

    Good luck,

    Bob

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    Robert Bard JD, RAC
    [Managing Director]
    South Lyon MI
    United States
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    Original Message


  • 5.  RE: recommended procedure before submission 510(k)

    Posted 23-Aug-2019 10:07
    Hello Lukas:

    A meeting with FDA prior to the submission of a 510(k) is not necessary - especially since it seems that all of your testing has been completed.

    FDA does provide a pre-submission program, but it is best utilized in the early phases of device development and regulatory planning and/or if there are specific questions you would like FDA to answer. 

    If you are confident with your predicate device and believe that you've completed all required testing, you can submit directly to FDA without a meeting. Be sure you include a ecopy that meets the guidance to ensure your device gets through the document mail center. 

    Good Luck!

    ------------------------------
    Andrea Pilon Artman, MS, CQE, RAC
    President & Principal Consultant
    SpectRA Compliance, LLC
    Frederick, MD
    USA
    andrea.artman@spectracompliancellc.com
    ------------------------------

    Original Message


  • 6.  RE: recommended procedure before submission 510(k)

    Posted 23-Aug-2019 10:30

    This is a more complicated question than you might think, because the answer is, as usual, "it depends."

    The type of meeting you mention is generally called a Q-sub meeting. There is a guidance and process on these, but generally it involves submitting the information to FDA, along with questions you'd like to discuss, and asking for feedback. This can be really helpful for your first 510(k), a complicated 510(k) etc. However, as you can imagine, it also takes a fair amount of time, none of which "counts" toward the 510(k) review time.

    But....if you don't do one, you have some risk of having FDA "refuse to file" your 510(k) because some content they need isn't present (or they can't find) or the formatting is off. Even if they file it, there may be an increased risk of rejection due to misunderstandings of requirements.

    That said, I'd tend to pass on the meeting if you can ensure the following:
    - all FDA guidance on content and formatting has been followed,
    - the device has a really clear predicate, ideally with a guidance document that you have followed,
    - your US agent filing on your behalf is experienced and has reviewed the submission for all the above (note you do need a US agent)

    If any of the above are not true, I'd tend to lean on the side of having the Q-sub meeting, but it is certainly not a "requirement."

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


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