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  • 1.  Experiences with 510(k) Exemption & 513(g) Requests

    Posted 26-Oct-2016 15:46

    I would like to ask for the help of RAPS Forum members in their experiences with the following:

    1. Use of the 510(k) exemption pathway for a new product from a new manufacturer (not just a line extension or modified product from an existing manufacturer where you are confident that the product is 510(k) exempt).  If you determined that a device was exempt and could be marketed without a 510(k), how confident were you that the product met the generic device description in the product classification regulation?  How did you document this?  Were you concerned about any slight differences between the new device and the generic description?  What is your perception of the risk in this approach?

    2. Use of the 513(g) request process to support #1.  If you filed a 513(g) request regarding whether a particular product fit the product classification regulation, did you get a confirmatory response from FDA?  Was this process helpful in gaining confidence about using the 510(k) exemption pathway?

    Thanks in advance for any help you can provide!

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    Julie Broderick RAC
    Broderick Regulatory Consulting, LLC
    Winchester MA
    United States
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  • 2.  RE: Experiences with 510(k) Exemption & 513(g) Requests

    Posted 26-Oct-2016 23:00

    I think this comes down to the company's tolerance for risk.  I recently considered the 513(g) in this situation, but I just didn't see how it was worth the time and money just to gain confidence.  Neither did my client.

    I think in your situation the only other option would be a De novo?  In that case, I'm more inclined to be "in for a penny, in for a pound."  Either take the risk or don't take the risk, rather than trying to take it, but not really.

    I chose to focus more on identifying and mitigating risks you would exposed to if you choose to go on the market as 510(k) exempt, but don't seek FDA confirmation, and then some day FDA comes along and shares its unsolicited opinion with you.  My client was comfortable with this approach, which might or might not be comfortable for you, depending on a variety of factors.

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

    Original Message


  • 3.  RE: Experiences with 510(k) Exemption & 513(g) Requests

    Posted 27-Oct-2016 05:06
    We frequently help clients make that assessment and it almost always involves some degree of risk if you market without clearance because if you ask FDA I can almost invariably tell you what the answer will be.  If you market without asking FDA you may go on uneventfully for years and suddenly come to FDA''s attention.  If you get a warning letter on an arguably exempt device, they will usually engage in enforcement discretion while you get a 510k on file and cleared.  Don't ask them if you can market during the filing period because you will get an answer you do not like.  



    Sent from my Verizon, Samsung Galaxy smartphone



    Original Message


  • 4.  RE: Experiences with 510(k) Exemption & 513(g) Requests

    Posted 27-Oct-2016 09:34

    Well...I always say that I can argue anything. :)  And that "denial" isn't just a river in Egypt.  I think companies can easily persuade themselves that a device is more arguably SE to a predicate which suits them (and not having to file anything with FDA premarket tends to suit almost everyone to a tee) than it actually is, and that its argument to support SE is more compelling than it is.

    So my question is, what happens if FDA shows up and decides that the device is not at all arguably SE to the 510(k) exempt predicate, and, moreover, that it seriously doubts that you ever really thought that it was?

    My other question is, other than a for-cause inspection, for which FDA presumably sends in an A+ team, how likely is the inspector who shows up going to be in a position to seriously question a claim of SE?  That's a pre-market issue; inspections tend to focus on post-market issues, and post-market inspectors tend to have qualifications in areas related to post-market issues.   I know these things do get caught in post-market inspections, but I've wondered if that's more the exception than the norm.

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

    Original Message


  • 5.  RE: Experiences with 510(k) Exemption & 513(g) Requests

    Posted 27-Oct-2016 05:07
    I would not use the 513g process...



    Sent from my Verizon, Samsung Galaxy smartphone



    Original Message


  • 6.  RE: Experiences with 510(k) Exemption & 513(g) Requests

    Posted 27-Oct-2016 08:08
    Edited by Adam Cargill 27-Oct-2016 08:10


  • 7.  RE: Experiences with 510(k) Exemption & 513(g) Requests

    Posted 27-Oct-2016 08:46

    Hi, Julie,

    I have used the FDA's Product Classification Database to find products similar to mine.  Once I find a product with the closest definition I decide if it is reasonable and can be defended in an inspection.  That will give you the classification, the Product Code, Regulation Number, etc.  I document the rationale including a list of similarities and, if necessary, recruit a PD engineer to write an opinion to include.  Based on that I use that Product Code when I list the product with the FDA before product release.

    Here is a link.  (Try control+click to access) 

    Product Classification

    Fda remove preview
    Product Classification
    a list of all medical devices with their associated classifications, product codes, FDA premarket review organizations, and other regulatory information.
    View this on Fda >

    I have not used the 513 (g) and would agree with Julie O. that you could use this if you are in doubt and do not want to risk the consequences of the FDA not agreeing with you.

    Regards,

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    John Minier RAC
    Sr. Regulatory Compliance Consultant
    JMC Medical, LLC
    Highland Mills NY
    United States

    Original Message


  • 8.  RE: Experiences with 510(k) Exemption & 513(g) Requests

    Posted 27-Oct-2016 09:15

    Thank you all for your feedback.  It confirms what I suspected about using an exemption.  I appreciate the help!

    Julie

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    Julie Broderick RAC
    Broderick Regulatory Consulting, LLC
    Winchester MA
    United States

    Original Message