Regulatory Open Forum

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  • 1.  Complaint Investigations

    This message was posted by a user wishing to remain anonymous
    Posted 30-Apr-2018 12:20
    This message was posted by a user wishing to remain anonymous

    Hello. Can anyone tell me if an "investigation" is required for every medical device complaint? According to 21 CFR 820.198, an investigation is only necessary if the complaint involves the possible failure of a device, labeling, or packaging to meet any if its specifications, unless such investigation has already been performed for a similar complaint then another investigation is not necessary. We had an FDA inspector tell us that every complaint requires an investigation. Is that true?

  • 2.  RE: Complaint Investigations

    Posted 30-Apr-2018 13:56
    Edited by Vidya Jayaraman 30-Apr-2018 13:56
    My understanding is YES. The FDA definition of a complaint is "Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution".

    The source of the complaint may be alleging any or all of the above deficiencies and how would you know without an investigation whether or not the device design/labeling/packaging caused the deficiency?

    There are 3 instances when a complaint investigation is not possible/needed:
    - when there's a duplicate complaint (identically same as the previous complaint, must be documented as such)
    - when there's not enough information to proceed with an investigation even after all attempts have been made to reach the source (document as such)
    - any safety/efficacy/product deficiency issue prior to distribution
    But keep in mind, 'investigation' could entail a different set of procedures for your company based on your complaints SOP. You may choose to do a full-fledged or preliminary investigation as soon as your receive a complaint, as dictated by your procedures. But the point i'm trying to make is that you must make the determination that it is not a duplicate complaint and you have all the required info for further course of action (assess for MDR, recall etc). Investigation could start right from the point of documenting the complaint or only after you've assessed its not a duplicate.

    Vidyalakshmi Jayaraman
    Marlborough MA
    United States

  • 3.  RE: Complaint Investigations

    Posted 01-May-2018 05:03
    The default answer is yes, but as Vidya explained there are some instances that you may not have to perform a complaint which she has well listed there.  I just wanted to make an additional note that your procedure should clearly explain how and when an investigation is performed ... or not performed.  In your complaint record there can be a "checkbox" that Investigation Required? Yes/No or something similar and if not required, then a rationale or justification.  While the FDA inspector is partially correct, the more correct statement should be that every complaint should be evaluated for complaint investigation and performed if required.  Obviously a complaint investigation is very limited on product that is not returned for evaluation.  You may perform a DHR review, a manufacturing review, or retained sample review.  For a high risk Class III device all efforts should be made and I would tend to agree that a complaint investigation is required in all cases.  But if you have a low risk disposable product, this may actually not be worth the effort as some customers just wanted free product.  I know - what a concept ! Though unfortunately it does happen wanting replacement free product when the initial may or may not have worked according to indications.

    Richard Vincins RAC
    Vice President Regulatory Affairs

  • 4.  RE: Complaint Investigations

    Posted 01-May-2018 07:19

    An investigation is not required for every complaint. However, there are four cases that require an investigation, not three. 820.198(d) includes, "Any complaint that represents an event which must be reported to FDA under part 803 of this chapter shall be promptly reviewed, evaluated, and investigated by a designated individual(s) and shall be maintained in a separate portion of the complaint files or otherwise clearly identified."

    Often, there is confusion between complaint evaluation and complaint investigation. The evaluation requirement is in 820.198(b), "Each manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary".

    The QSR preamble, section 190 clarifies. "Section 820.198(b) discusses the initial review and evaluation of the complaints in order to determine if complaints are 'valid'. It is important to note that this evaluation is not the same as a complaint investigation. The evaluation is performed to determine whether the information is truly a complaint or not and to determine whether the complaint needs to be investigated or not."

    The requirement is to evaluate all complaints but investigate a subset.

    Dan O'Leary
    Swanzey NH
    United States

  • 5.  RE: Complaint Investigations

    Posted 01-May-2018 08:48
    My understanding is that if you don't do an investigation you need say so and why it isn't required.
    My use language like " Complaint Closed, no investigation required. xxxxxxxxxxxxx. Where the xxxxxxx is the justification as to why no investigation was required. This can be a number of reason depending on the nature of your device.
    I hope this helps.
    Keri Froese RAC - QA Manager

    Keri Froese RAC
    Quality Assurance Manager
    Dunrobin ON

  • 6.  RE: Complaint Investigations

    This message was posted by a user wishing to remain anonymous
    Posted 01-May-2018 15:12
    This message was posted by a user wishing to remain anonymous

    Thank you all. Your feedback confirmed what I had thought.

  • 7.  RE: Complaint Investigations

    Posted 04-May-2018 08:18
    Not necessarily and here is the guidance citing from the FDA website for inspectors:

    Determine if the firm has performed sufficient complaint investigation, or to the extent possible, to confirm the reported failure mode.

    Determining Whether An Investigation Is Necessary - 21 CFR 820.198(b)

    The firm should evaluate complaints thoroughly to determine whether an investigation is necessary. Indicators that the firm may not be in compliance would be shown by:

    1. A history of one or more similar failure modes and has not investigated to confirm the reported failure mode.
    2. The complaint records lack the reason for not investigating and/or the name of the individual responsible for the decision not to investigate
    Here is a PowerPoint(R) presentation from the FDA website which also infers that not all complaints require investigations (specifically slide 9).  It also reiterates your citing of "when" an investigation is necessary.

    I have always been trained to document why an investigation has not been performed.  The only issue we have had with our complaint system during FDA inspections is that from 803.3 in "becoming aware".  We were recently given this scenario....a manufacturing associate is visiting someone in the hospital.  They are discussing where they work and what they do. A nurse over hears the conversation and says something like we don't use those anymore/we aren't allowed to use them because we had 4 pt injuries or they break all the time, etc.
    They are required to be trained in complaints so they know that is a complaint and they can report the information to the "dedicated" entity for data gathering to determine the need for an investigation.

    Bottom line is that all the information on the FDA website indicates that not ALL complaints require and investigation.  That is how our SOP and WIs are written and our most recent inspection was last December.  However, if you sell into Canada, that's an entirely different ballgame!

    D Michelle Williams
    United States