Regulatory Open Forum

 View Only
  • 1.  Complaint investigation

    This message was posted by a user wishing to remain anonymous
    Posted 21-Feb-2019 08:34
    This message was posted by a user wishing to remain anonymous


    Have read through the posts on this topic , but I am still unclear ...

    As per 21 CFR 820.198

    (c) Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary.



    Also the inspection guide mentions :


    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.


    Would you be able to clarify if the complaint involves failure modes which are already identified during the design phase and have been included in the user manual , also confirmed by the service tech during device verification, is that sufficient investigation for the non MDR related complaints? Also if the trends do not trigger further investigation ?

    Thanks ,