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  • 1.  Clarification on limitations of 510(k) exemptions in §882.9

    Posted 17-Mar-2020 10:08

    Hi all, 

    I am working on identifying the proper regulatory path for a device that most closely matches §882.5050-Biofeedback device. Per the classification regulation, this generic type of device is exempt from premarket notification with some conditions and with the exemptions found in §882.9. 

    In §882.9(a) I read that manufacturers of exempt devices must still submit a 510(k) when the intended use of the device is different from the intended use of a legally marketed device of that generic type (which I read as "the predicate device"). However, if this were the case, and the intended use of the new device were different than the intended use of the predicate device, wouldn't this result in a determination of NSE? In this case, wouldn't the correct path be to submit a de novo application and skip the 510(k) completely?

    I'm struggling to understand why the regulation recommends the submission of a 510(k) for a different intended use, as my understanding is that such and application would result in an NSE determination.

    Appreciate hearing your thoughts. Hope everyone is hanging in there!

    Aimee



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    Aimee Feuser
    Chicago, IL
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  • 2.  RE: Clarification on limitations of 510(k) exemptions in §882.9

    Posted 18-Mar-2020 02:53
    Two aspects to this.

    First: is the intended use genuinely different.  Intended Use is an engineering statement of what the device does, and can be very generically written and interpreted.  And it's NOT the same as Indications for Use - which is a clinical statement of the disease or condition you will use the device to treat or diagnose.  So ask yourself if your device can be ascribed an intneded use that is broadly the same as that described in the regulation.

    Paraphrasing the regulation: the Intended Use of a Biofeedback device is "to provide a visual or auditory signal corresponding to the status of one or more physiological parameters so that the patient can control voluntarily these physiological parameters."

    Note that a specific condition you intend to treat or help the patient manage is not part of the Intended use.

    Second:  If you genuinely want to do something with your device that is outside the above intended use then yes you are caught by the catch 22 that you need a 510(k) but there won't be any predicates and your intended use is different.  In this case you are correct, the way out is via a de novo, and I would strongly recommend taking this to a presub with FDA to determine their expectations for testing and clinical evidence to support the new application.

    Arthur


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    Arthur Brandwood PhD FRAPS
    Director and Principal Consultant
    Brandwood CKC
    Sydney, Australia
    Arthur.brandwood@brandwoodckc.com
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    Original Message


  • 3.  RE: Clarification on limitations of 510(k) exemptions in §882.9

    Posted 18-Mar-2020 07:50
    Thanks so much, Arthur

    What would the recommendation in the case that the company believes that their device falls within this generic intended use statement, and is therefore exempt from 510(k), but still believes there is a small chance that the FDA would disagree once the product was on the market. I have seen instances where a company's take differed from the FDA (resulting in fewer controls), and this resulted in a warning letter and the need to pause marketing until a 510(k) could be submitted and the device cleared. Not a pretty picture for a manufacturer and one I would want this company to avoid if at all possible.

    Aimee

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    Aimee Feuser
    Trestlework, LLC
    Chicago, IL
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    Original Message


  • 4.  RE: Clarification on limitations of 510(k) exemptions in §882.9

    Posted 18-Mar-2020 08:59
    Aimee,

    You are looking at one of the regulations that has a bit of quirks regarding regulatory strategy because there are so many different type of products put in that regulatory "bucket" under biofeedback device.  If you do not have a strong predicate device with the same intended use/indications for use statement, then most likely you will be looking at a De Novo.  There are a few regulations where a 510(k) is still required or there is no class - which means you should contact the agency through the Q-Submission process in advance to understand what would be expected for your device.  Those devices that exceed the limitations of the regulation 8xx.9 is highly recommended to contact FDA in advance to determine the proper regulatory strategy.  You can of course always sub it a 510(k) first (or even place on market/sale) but you might be having much more regulatory difficult and much time and energy spent rather than just approaching FDA in advance.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 5.  RE: Clarification on limitations of 510(k) exemptions in §882.9

    Posted 18-Mar-2020 09:36
    Aimee,

    Not an expert on that type of device, but I believe generally what you see here are evolving De Novo processes. Back before de novo, FDA routinely used new 510(k) to manage new indications or devices with relatively understood safety profiles. Yes, occasionally things got held up, or kicked to PMA, but rarely. Then, at first de novo required you to get an NSE determination, so of course you'd submit a 510(k) first.

    These days, I get the feeling there is still some morphing of indications via 510(k) - probably primarily on Class 2 devices that are not exempt, but maybe less than there was.

    Your particular question seems like the perfect discussion for a Q-Sub, IMO.

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


  • 6.  RE: Clarification on limitations of 510(k) exemptions in §882.9

    Posted 23-Mar-2020 10:14
    Thanks so much, Ginger. 

    Is there risk that a Q-Sub that is based mostly around understanding the correct classification a pertinent requirements would get kicked by the FDA to a 513(g)? I feel weird initiating a Q-Sub when it seems like 513(g) is the appropriate mechanism, but it seems that many try to avoid the 513(g) and go for the Q-Sub when at all possible.

    Aimee

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    Aimee Feuser
    Trestlework, LLC
    Chicago, IL
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    Original Message


  • 7.  RE: Clarification on limitations of 510(k) exemptions in §882.9

    Posted 23-Mar-2020 10:19

    There is a small risk of this – but generally you can work around it by structuring your Q-sub not around the "classification" but around "the wording of the indications for use" and basically bring in an argument that you believe the current Class 1 code covers it. You can rest assured that FDA will tell you if they disagree w/out a 513(g). And if they do disagree, you can always take another shot via that process.

     

    g-

     

     




    Original Message


  • 8.  RE: Clarification on limitations of 510(k) exemptions in §882.9

    Posted 19-Mar-2020 10:06
    To my knowledge, in the context of determining whether the limitations of exemptions from 510(k) are exceeded, a generic type of device is the device described in the classification regulation and not the predicate device. If a 510(k) was required for the predicate, and your product has the same intended use as the predicate then a 510(k) is likely required. If the classification regulation were revised to include additional indications that would be a different story.

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    Jeffrey Freedman
    Regulatory Affairs Specialist II
    Lowell MA
    United States
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    Original Message


  • 9.  RE: Clarification on limitations of 510(k) exemptions in §882.9

    Posted 19-Mar-2020 10:16
    Ahhh, that makes perfect sense. I see where I was getting mixed up there. Thank you!

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    Aimee Feuser
    Trestlework, LLC
    Chicago, IL
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    Original Message


  • 10.  RE: Clarification on limitations of 510(k) exemptions in §882.9

    Posted 23-Mar-2020 10:21
    Aimee,

    Submitting a 513(g) versus Q-Sub is a fine line because if you are really seeking product classification, the FDA would kick it back to 513(g).  There are two aspects with a 513(g) 1) there is a cost with this and 2) there is a specific structure for this classification request.  The only time I have been able to get a classification confirmation in a Q-Sub is having it bundled with some other questions as such.  But yes, they will kick it back if you submit a pure classification request as part of Q-Sub (Q-sub is free and format is not specific for classification).

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


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