Regulatory Open Forum

 View Only

  • 1.  Old Complaints - not reported

    This message was posted by a user wishing to remain anonymous
    Posted 04-Apr-2018 08:59
    This message was posted by a user wishing to remain anonymous

    ​

    If during review of the old records of medical device complaints (10 – 15 years old), we find there are ones which were reportable and not reported, what should we do now ?

    Thanks



  • 2.  RE: Old Complaints - not reported

    Posted 05-Apr-2018 08:17
    The higher regulatory risk is write justification and rationale in the complaint file that it should have been reported and was not done.  Then complete a very thorough analysis of the complaint history, corrections made, corrective action, and whether the issue still exists (even if periodically).  The least regulatory risk is to report them now.  While it does not make sense and a huge time factor in generating the documentation, the FDA does not have any "time bounds" meaning they can go back in your documentation as far back as they want.  I have been in inspections where it was older than 5 years that the investigator said we should have reported ... meaning report it now and I won't continue to be too hard on you.  There is different levels of regulatory risk that your organisation can take for that, so you will have to determine if you do report those.  Certainly FDA's MDR system is a bit overloaded, but at one company I worked for, we reported even if their was any probability - so even if it was old - we would have reported it at the current time.

    ------------------------------
    Richard Vincins RAC
    Vice President Regulatory Affairs
    ------------------------------

    Original Message


  • 3.  RE: Old Complaints - not reported

    Posted 06-Apr-2018 16:39
    I agree with Richard, since you have found an issue during a review and part of the correction would be to report and show you are compliant.   Of course, you'll have to be ready for the possibility that the FDA will ask follow up questions, and, in the worst scenario, trigger some type of audit (hopefully unlikely).   However, choosing to not report is a riskier option as you might be seen as knowingly covering up a non-compliant item found during an internal review.    

    If the product is still in use, I'd say you must report.   If the product is not is use and not sold, then it's a tougher issue that needs to be put into context with other business goals/concerns (e.g., are you already worried about your next audit or are you already in hot water with the FDA on something else).

    ------------------------------
    Roger Cepeda, JD, MBA, RAC
    MedTech Law LLC
    roger@medtech.law
    Mobile: 847-421-8361
    ------------------------------

    Original Message


  • 4.  RE: Old Complaints - not reported

    This message was posted by a user wishing to remain anonymous
    Posted 16-Apr-2018 09:09
    This message was posted by a user wishing to remain anonymous

    Continuing on the same topic , another clarification requested..
    ​How would you treat reportable corrections (recalls) which were not reported years ago ?

    Thanks,
    Original Message


  • 5.  RE: Old Complaints - not reported

    Posted 17-Apr-2018 05:52
    In a short answer: the same way.  Probably the difference between an Medical Device Report and a Recall is that the materials or product that are subjects of the recall are not available or had been distributed quite some time ago (maybe with expiration dates).  The likelihood of actually reporting a recall is much less, though it should still be documented clearly in your system what happened, why it did not happen, what was done, what was not done, etc.  Handle it just like a regular recall with all of the documentation, just you may not report a recall currently especially if the product is no longer available.  However, be ready for some really difficult questions during an inspection.

    ------------------------------
    Richard Vincins RAC
    Vice President Regulatory Affairs
    ------------------------------

    Original Message


Related Content