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  • 1.  Your Fastest 510(k) Ever?

    Posted 18-Feb-2017 13:51

    I would like to get some kind of baseline answer to the perennial question, "How long is it going to take" for the compilation of a 510(k). 

    - By "some kind of," I don't mean a single figure, but at least a range, perhaps along with some information about what variables can have a significant impact on the amount of time it takes. 

    - By "compilation," I mean just the time it took to put one together, not time spent researching the device, intended use, regulations, guidances, standards, etc, nor time spent going back and forth with team members to get additional information, clarifications, and explanations, nor time spent trying to determine whether the information that has been provided is adequate to support clearance.

    I think no one really knows exactly how much time they spend on this type of project, because there are typically too many interruptions, detours, etc, to keep track of every minute. The ideal situation would be for someone fully knowledgeable about the device, intended use, regulations, guidances, standards, etc, to receive a neat package containing all of the information needed for the 510(k), and then be able to work uninterrupted from start to finish. Since that never happens (does it?), I’m assuming the best anyone can provide is a reasonably good guesstimate, not a hard figure.

    So:

    What is your (guesstimated) fastest ever 510(k) compilation time (in hours worked, not in calendar time)?

    It would also be helpful to know whether you compiled your fastest 510(k) ever as an employee or consultant, for a start-up, large established company, or a mid-size manufacturer, and the general therapeutic area of the device’s intended use.

    Any thoughts on WHY it went so quickly would also be of interest.

    Thanks in advance for sharing your experience here in the RAPS Forum!



    ------------------------------
    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
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  • 2.  RE: Your Fastest 510(k) Ever?

    Posted 21-Feb-2017 10:28
    Hello Julie,

    This is an interesting question. My fastest 510(k) was for a dental mouthguard. The predicate included no <g class="gr_ gr_592 gr-alert gr_spell gr_disable_anim_appear ContextualSpelling ins-del multiReplace" id="592" data-gr-id="592">biocompatability</g> testing and used the same materials as the subject device. The device was simple - no moving parts, no electrical components, no software, etc. This was for a small company and the simplicity of the device is what made the difference. I would guess drafting was under 15 hours!

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    Marc Sanchez
    Regulatory (FDA/USDA) Attorney and Consultant/Adjunct Professor
    FDA Atty Law Firm (CIHCC, LLC)
    Charlotte NC
    United States
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  • 3.  RE: Your Fastest 510(k) Ever?

    Posted 22-Feb-2017 18:01
    That seems like a reasonable timeframe to me.

    I'm taking the lack of other replies to mean that not too many people have worked on a 510(k) that they are able to think of in terms of "fast," much less "fastest." :)

    ------------------------------
    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
    ------------------------------



  • 4.  RE: Your Fastest 510(k) Ever?

    Posted 01-Mar-2017 08:53
    In my case, it is because I have rarely just "written" the 510(k) in a single writing. For a couple Specials, yes, and those probably only took me 10-15 hours of work total. However, the vast majority of submissions I have ever written I have done incrementally. So, once the design freeze is done I can write the device description section (and have it reviewed and edited). Once each part of the testing is done I can write those sections. As we pick the predicates I draft out what you want the comparison tables to look like etc. Generally I have submitted the fully reviewed 510(k) within 3-5 days of the final data being "ready" (which as you know can mean different things in different situations) but only because of all the incremental work along the way. In working this way, I don't think I have ever kept track of the hours closely enough to say how long the entire 510(k) took to write.

    g-

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    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States
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  • 5.  RE: Your Fastest 510(k) Ever?

    Posted 01-Mar-2017 15:47

    Yes, I think this is how it is commonly done inside a company, making it difficult to gauge the overall amount of time required for a particular task of any complexity.  Consultants have a little better shot at it, because some clients don't show up until they (think they) are ready for someone to "do" their 510(k).  As in Mark's example, every once it a while it turns out that they are right.



    ------------------------------
    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
    ------------------------------