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  • 1.  513(g) request or Pre-Sub

    Posted 12-May-2019 10:50
    Hello, 

    Can somebody clarify the circumstances where 513(g) may be used  versus a pre-sub written request/meeting? Can pre-subs also be used for making classification requests? 

    What are some advantages and disadvantages of each option? 

    Thanks.

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    Karen Zhou
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  • 2.  RE: 513(g) request or Pre-Sub

    Posted 13-May-2019 03:23
    513(g) = device classification
    Pre-Sub = feedback on regulatory activities

    If you read the regulation under 513(g) this is for device classification as if your device is new and novel, this might be where they respond saying De Novo may be possible.

    The Pre-Sub or Q-Submission process (because it is assigned a "Q" number) typically used for feedback on a various regulatory activities including things like protocol review, IDE submissions, performance testing,, comparison testing, etc.

    If you submit a device classification using Q-Sub process it most likely will be kicked back and told to use the 513(g) as this is a prescriptive process for device classification.  However, you can use Q-Submission after the 513(g) for things like clarifying predicate device selection, De Novo possibility, etc.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: 513(g) request or Pre-Sub

    Posted 13-May-2019 04:47
    I agree totally with Richard, for a classification request it is a 513(g). However, do not use this lightly, it is much better to the classify your product yourself, if at all possible.

    Sometimes, if FDA do not understand why you chose a particular classification and feel another may be more appropriate, or if they want to introduce a subtlety between two similar classifications, or if they are working on a new product code, there can be an interactive discussion during review.

    Neil

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    Neil Armstrong FRAPS
    CEO MeddiQuest Limited
    Peterborough
    United Kingdom
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    Original Message


  • 4.  RE: 513(g) request or Pre-Sub

    Posted 14-May-2019 08:29
    I disagree with this a bit. Yes, 513(g) is the way to get a "binding" decision. However, binding means binding - FDA will not change their mind later so you are generally stuck with their decision. If, instead, you want to open up a conversation, you can do so via a Q-sub. This leaves the opportunity to, perhaps, answer questions FDA has in the future in the interest of getting a mutually agreed upon and perhaps less conservative decision. I have had great luck with this in the past, as it opens up a conversation that often leads to a lot of clarity on both parts, but with room to evolve. Of course, the downside is that it isn't binding and a change in personnel at FDA can change the feedback you thought you had.

    Thus, which to use kind of depends on the goals your business has for the development of the product.

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


  • 5.  RE: 513(g) request or Pre-Sub

    Posted 13-May-2019 14:52
    Advantage of pre-sub - you can ask questions and FDA can answer questions.  It's more interactive.   However, you will not get a definitive answer if you do not already know if your product is a medical device.    Advantage of 513(g) - a definitive answer if the product is a medical device.

    I agree with the others.  If you can, determine first if the product is a medical device on your own, and then use a pre-sub to clarify your path to market.  If the product is so novel, that there really is nothing to compare it to, then you may be stuck with a 513(g).

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    Tracey Fox RAC
    Global Regulatory Affairs
    Pewaukee WI
    United States
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    Original Message


  • 6.  RE: 513(g) request or Pre-Sub

    Posted 13-May-2019 19:07
    It seems a lot depends on what you are comfortable determining on your own and where you are at a loss.  Given the time and money required for a 513(g), and the fact that whatever feedback you get from FDA is not binding, I would not be inclined to do a 513(g) unless I was at a loss, or the question was especially critical for some business reason.

    It should be noted that the FDA's guidance on 513(g) requests was issued prior to FDASIA and makes no reference to a De novo.  Since early feedback on the De novo process identified the classification part (as opposed to the safety & effectiveness part) as the biggest challenge, it might be good to get a head start on classification if you are planning to submit a De novo, in the hopes of expediting that part of the process during the actual review of the De novo request.

    I will also note that the 513(g) is a request for information.  It is the De novo that is a request for classification.






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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 7.  RE: 513(g) request or Pre-Sub

    Posted 14-May-2019 10:09
    It has been my understanding (don't know) that 513(g) feedback is not binding.  I didn't read the entire guidance, but I did some keyword searching.  I didn't find anything definitive, but I found some language that I always take as indication of the Agency hedging its bets (bolding is mine):

    "...based solely on the information provided in the 513(g) Request for Information; it appears that the product you have identified is:"

    And then it goes on to provide a bulleted list in which "it appears to be" is repeated several times.

    There is also this language:

    "A 513(g) response does not constitute final Agency action, but provides responsive information based on the information provided by the requestor."

    Plus it is a request for "information," not a decision, is how I take it.

    But mostly, FDA hates to get bound to anything in advance of a full premarket review, and I wouldn't want to get bound, either. Things change.  I think this is my main reason for thinking this feedback is not binding.  But again, I don't know.  If anyone has seen some language that clearly states otherwise, I'd be happy to be disabused of this notion.

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 8.  RE: 513(g) request or Pre-Sub

    Posted 15-May-2019 09:52

    Well, the section of the law implies they are supposed to be binding, but, IMO, nothing is binding with CDRH these days – including previously cleared 510(k)s – as I know personally.

     

    g-

     

     




    Original Message


  • 9.  RE: 513(g) request or Pre-Sub

    Posted 15-May-2019 10:28
    Yes, I agree about the language in the Act, but that may have been a mistake on the part of Congress.  If it had wanted it to be binding, it should have said so, unambiguously.  But I would guess that Congress doesn't know FDA nearly as well as we do.

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


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