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.
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Vidyalakshmi Jayaraman
Marlborough MA
United States
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Original Message:
Sent: 30-Apr-2018 12:12
From: Anonymous Member
Subject: Complaint Investigations
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?