Regulatory Open Forum

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  • 1.  Hello everyone,

    Posted 12-Jan-2017 14:48
    Is anyone aware of a Catch up 510(k) for Medical Devices. Has anyone done or thought of similar kind of submission?
    Please advise and provide inputs if any.

    Thanks,
    Aliva Das
    Regulatory Associate
    Glidewell Dental Labs


  • 2.  RE: Hello everyone,

    Posted 12-Jan-2017 21:40
    I haven't done one, but yes, I've heard of them.  I can think of  two reasons to do a catch-up 510(k):

    1)  It will facilitate future product development by giving you a "clean" 510(k) to serve as a basis for future modifications or future devices for which you might use the "caught up" device as a predicate.

    2) "Pay me now or pay me later."  By this I mean you are starting to get the uncomfortable feeling that your device has morphed bit by bit by bit over time to the point that maybe it might not bear close regulatory scrutiny today.  So, better to subject it to scrutiny now, and deal with the results of that scrutiny now, than keep putting it off until one day scrutiny happens, and by then it's gotten even more out of hand and you have a major regulatory headache to deal with.  Also, the general wisdom is that such things will always go better with FDA if you bring it to their attention on your own initiative, rather than waiting for FDA to bring it to yours.

    Of course, whenever you ask FDA to look at something, you can't know what its response might be, so you would want to think about worst case scenarios and be prepared to deal with them if need be.  From the perspective of the regulatory professional, you want to make sure your management fully understands the pros and cons and is fully on board (in writing, so it really happened) with the idea.


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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
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  • 3.  RE: Hello everyone,

    Posted 13-Jan-2017 03:49
    Hi Aliva:
    I am not sure exactly what you mean by a "catch-up", but I think you mean where there have been some changes under letter-to-file since the last 510[k] and some more that you intend to make;  you take the view that the cumulative effect of the changes is sufficent to require a new 510[k]. This can be either a special (if you own the last 510[k] for the product/product) or traditional/abbreviated if not or if more substantive. We have certainly assisted customers with both and had no particular problems.
    You do need to be careful to explain clearly what features have not been changed, so are identical to the already cleared predicate and so do not need much review by FDA, and what features have been changed but you are claiming substantial equivalence - clarity avoid FDA unnecessary additional review by FDA.
    Hope that helps and I have not misunderstood the point!
    Neil

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    Neil Armstrong RAC FRAPS CEO MeddiQuest Limited Cambridgeshire United Kingdom
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  • 4.  RE: Hello everyone,

    Posted 16-Jan-2017 13:51
    First, it is important to note that "Catch Up 510(k)" is not an official term in any way, shape or form. Think of it instead as "professional jargon." Yes, I, and/or my staff, have done a few of these over the years. As the moniker implies, the intent of these 510(k)s is simply to update or "catch up" with changes made since the last filed 510(k). There are a variety of reasons you may want or need to do one of these, such as:

    - your ongoing assessment of incremental changes determines that the totality of these changes now makes the overall device need a new 510(k)

    - when you anticipate FDA expectations have changed significantly and you don't wish to have your big commercial update tied up in debating how you chose to tackle the change (think, for instance, the new guidance on cleaning and reprocessing reusable devices; you may feel you meet the new requirements, but do you want to risk your new features being caught up in a debate about whether your simulated soil was appropriate?)

    - when you "inherit" decisions (from an acquisition, new job etc) and do not feel comfortable with the legacy decision making

    These can be done as stand-alone 510(k)s or leverage a new minor change (much to be preferred). How much scrutiny the "previous changes" get seems to depend on the Branch and reviewer.

    G-

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    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States
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  • 5.  RE: Hello everyone,

    Posted 20-Jan-2017 20:38
    I concur with Ginger's feedback.  I've used a new minor change, one that wouldn't normally trigger a new 510(k), as the basis of filing a new 510(k) that allowed the company to "catch up" with the incremental changes over the years and establish a new base 510(k).

    Julie

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    Julie Broderick RAC
    Principal/Consultant
    Broderick Regulatory Consulting, LLC
    Winchester MA
    United States
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