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Justifying NOT following an FDA guidance?

Discussion in 'Medical Devices (21 CFR Part 820)' started by MarkMeer, Jan 5, 2016.

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  1. MarkMeer

    MarkMeer Well-Known Member

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    Hi Everyone,

    Just curious: has anyone (successfully) attempted to push-back against an FDA observation that items in one of their guidance documents is not being followed?

    Background:
    We just got our letter of 510(k) deficiencies of which a substantial portion is along the lines of "the FDA guidance says to include these warnings/precautions, yet you've not included them.."

    Now there is some debate here as to how to handle this:
    • Party A (path of least resistance) says: let's just capitulate, and add all the required warnings as written.
    • Party B (in favor of push-back) says: these warnings are not necessary, and will only confuse users (they are all medical-jargon heavy, and already covered by alternately-worded warnings already present). Besides, these are only guidance documents afterall...

    Presently, favor is leaning towards Party A (just doing as the FDA says).

    Can anyone advise, or share their experiences with contesting FDA 510(k) deficiencies?

    MM
     
  2. Ronen E

    Ronen E Well-Known Member

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    My experience says that path A is the way to go, if you desire a timely clearance.

    When preparing FDA submissions, I try to follow prescribed guidance (i.e. Special controls) as closely as I practically can.

    The term "guidance" is a little misleading in this instance...

    Cheers,
    Ronen.
     
  3. MarkMeer

    MarkMeer Well-Known Member

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    I'll say... :confused:

    Thanks for the input. This is the same FDA-interaction policy as with a previous company I worked with, the present company I work for, and (by the sounds of it) your approach as well: capitulate to everything the FDA requests.

    (sigh) ...and I can see why. Nobody wants delays (or worse, bad will) from the US FDA, so this "path-of-least-resistance" capitulation makes business sense.
    ...However, what really irks me is that it doesn't necessarily make safety & efficacy sense (which is the FDA's mandate, afterall).

    We'll probably end up just doing as they say...at the unfortunate expense of product usability (pages of medical jargon-heavy warnings will only detract from the average user's comprehension, and will also shift attention away from important warnings, which will be buried amongst all the requested additional warnings).

    I have a feeling that companies' general reluctance to challenge the FDA has, over the years, actually resulted in an atmosphere where FDA reviewers expect full capitulation, and hence many of the cited "deficiencies" is simply mission-creep, without actually having any positive effect on either safety or efficacy.
     
  4. Pads38

    Pads38 Member

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    We have a somewhat similar requirement, in that the EMC standard requires the inclusion of a series of data tables that are of no use to the "normal" user and must add only confusion (if anyone ever looks at the manual that is!).

    So I include them, but as an Annex to the Operators Manual - right at the back, printed small, along with some other information (recurrent test, service life, availability of service information) that will only be of use to a hospital's (or "Responsible Organisation") engineering department.
     
  5. MarkMeer

    MarkMeer Well-Known Member

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    Yes, same experience. But like you (and most, I imagine), I just placed the tables in a "Technical Information" section at the end of the manual.
    ...and while I generally disagree with mandatory information that arguably doesn't add value or safety, delegating such information to a "Technical Information" section, is not necessarily confusing to a user.

    But here we're talking about warnings/precautions that are typically prominent in the manual, and ARE important for the user to understand.

    They want us to replace our current warnings "Do not use on any part of the body except the intended leg.." and "Use only over clean, healthy, uninjured skin..." with:
    • "...should not be applied over the carotid sinus nerves..."
    • "...should not be applied over the neck or mouth. Severe spasm of the laryngeal and pharyngeal muscles may..."
    • "...should not be applied transthoracically..."
    • "...should not be applied transcerebrally..."
    • "...should not be applied over swollen, infected, or inflamed areas or skin eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc..."
    • and the list goes on for pages...
    How does this make any sense?! :confused: Especially as this is a device intended for home use by lay people...

    I made an inquiry in an FDA webinar regarding the conflict between guidance labeling and usability, citing these examples. The FDA spokesperson couldn't even pronounce the words "carotid", "pharyngeal", or "phlebitis" when reading out the question, let alone know what these terms mean... If people at the FDA don't even recognize these terms, it's pretty absurd for them to request we add them to our home-use/lay-person manual in the name of "safety and efficacy".

    Sorry for the rant... but this, to me, is a pretty clear example of regulations gone off the rails so as to actually be counterproductive. And the general advice from higher management and consultants throughout my career in such cases has always been "don't argue with the FDA, just do as they say".

    Frustrating... :(
     
  6. Ronen E

    Ronen E Well-Known Member

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    Mark, if you really believe that the current guidance is detrimental to users, why not petition / lobby for revision? In the meantime I would "just do what FDA says", yes. One is for the short term and the other for the long.
     
  7. MarkMeer

    MarkMeer Well-Known Member

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    To be clear: I have no problem with guidance documents per se. In general, I find them very helpful, and they contain a lot of valuable recommendations for designing safety, efficacy and usability into medical devices.

    What irks me is that they seem to have become defacto regulatory requirements documents. ...and the status quo that the best short-term business policy is to capitulate only further solidifies this trend.

    If I were to petition for change, it'd be not to revise the guidance document, but to reexamine 510(k) review process, and what constitutes a "deficiency".

    I guess I could send something to the CDRH, but I won't be holding my breath for change.. Are there other, more effective, means for a (foreign) manufacturer to voice concerns with FDA policy/documents that you are aware of?
     
  8. Ronen E

    Ronen E Well-Known Member

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    I'm not really in the business of advocating / lobbying for FDA guidance / policy changes, but I'm sure that if you're really interested in setting something in motion you could find the right handles on the FDA website. Another option is to try to get an industry association to apply on behalf of a class of manufacturers (in Australia we have MTAA for instance). I don't think that change will come quick or easy, but if you believe you have a valid argument (and it seems it might be the case), have enough patience and are willing to make an effort for it, I believe that you have a fair chance of eventually succeeding.

    Then again, you always have the option of just whinging, which is much easier and sometimes enjoyable... :)

    If you're looking for a more transparent and quick 510(k) review process (though more expensive), I suggest you look into the 3rd party review option - assuming that your device is eligible. I feel that under this option the manufacturer-reviewer relationship has a more sensible, commercial-like character (a bit like when working with a NB) than when working directly with FDA. The latter certainly has a more a-symmetrical nature ("they tell you to jump and you ask how high"...)
     
  9. MarkMeer

    MarkMeer Well-Known Member

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    'tis... ;)

    But my original post was really only intended to survey peoples' experiences & advice when it comes to interacting with the FDA.
    Unanimously, the prevailing wisdom appears to be that the best business policy is to capitulate to everything the FDA asks.
    I'm uncomfortable with this on many levels, and am really wanting to hear if there is another side (i.e. those who've successfully "argued" with the FDA).

    Interesting idea, though unfortunately, at this point, the FDA review process is already nearly done. ...definitely something to consider in the future..
    Anyone had any experience with 3rd-party 510(k) review process? I'd love to hear how it went...

    -----
    (thread topic divergence)

    It be interesting to discuss the merits & pitfalls of the two relationships. On the one hand, the "business" relationship lends itself to lack thoroughness, whereas an authoritarian relationship lends itself to over-regulation.
    ...topic for another thread, I suppose...;)

    In this particular case, I don't know that this is a cause that manufacturers would readily get behind - mainly to do with the lack of incentive.
    Rallying companies on principle, rather than economics, is (in my opinion) a lost cause - unless, of course, the two motivations intersect.

    In this case, there is little such intersection. Regulators want an extra 2 pages of warnings? Big deal. Just copy and paste, right? Hard to make a case that it makes any business (economic) sense to spend any significant resources in challenging this.
     
  10. Ronen E

    Ronen E Well-Known Member

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    I have successfully argued with the FDA, against initial review process requests that seemed illogical, when there was some wiggle room in the text. However, I never was in a blunt "Do this!" / "No I won't, it makes no sense" situation.

    Yes, it makes sense. Perhaps in this case it would make more sense to get behind a consumer representative group, as the cause is a more user-effective labeling.
     
  11. Jim Hagenbaugh

    Jim Hagenbaugh Member

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    The only possible argument you have is to asked where the requirement for the two pages is required.

    excerpted directly from an FDA Guidance Document
    "FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required."
     
  12. Ronen E

    Ronen E Well-Known Member

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    I hope I'm not being too blunt, but this is practically meaningless. This clause, in all modern FDA guidance, is dictated by their GGP (good guidance practices) and stems from legislation. In practice, final guidance is treated almost like regulation. One might try and drag FDA to court and maybe even win, but most people realise that this usually makes much less business sense than just playing along.

    If you try the "where does it come from" route, they will most likely dump on you a ton of references to requirements related to device safety. There's no doubt about the requirements; the argument is about what's most effective in meeting them. FDA doesn't have the resources or will to analyse each and every manufacturer's version to safety warning so they opt for the easy way - standardization. I'm not saying I like it, I'm just saying that it is what it is and the only alternative to submitting is a lengthy debate with questioned success chances. Most companies just don't have the taste for the latter.
     
  13. MarkMeer

    MarkMeer Well-Known Member

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    (whinging again...)
    It's really too bad that (unlike, for example, quality system audits), there is no onus or expectation that the FDA justifies their cited deficiencies, using references to actual regulations.

    Intentional guidance deviations aside, I thought our submission was, if anything, OVERLY thorough, and yet there were a number of "deficiencies" we got cited that seemingly came out of nowhere (e.g. "please collect data regarding X", or "please label your figures this way"), without any reference to where or why these are needed (aside from the implicit "because we want it that way...").

    I'm astounded that ANY company can pass though a 510(k) without any deficiencies, seeing as the definition of "deficiency" appear to be highly malleable and interpretive.
     

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