Per 21CFR 820.198 (b) - Justification for no investigation

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#11
Per 21CFR 820.198 (b) "When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate." I realize we can reference a previous investigation for the issue/product, but if there isn't a previous investigation, what are some reasons why an investigation would not have to be done? The company I work for manufacturers low risk medical devices and cosmetics.
There was already a review of an item for MRB for a non-conformance and it was used in any case after a risk review and disposition and corrective action. A complaint based upon that NCR might not require an investigation. It would need to reference the risk review and CA.
 
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Watchcat

Trusted Information Resource
#13
Part of complaint intake always includes a description of the device itself. If the device is literally not something that you are not responsible for, there is no need to investigate.
And how do you know it is not your device without investigating? Because the complaint intake says so? If the complaint was directed to you and it says it is not your device, then an error was made. Was the error in directing the complaint to you? Or was it in the description of the device?

Believe me, it is possible to receive complaints for a competitors device.
Tell me about it.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#14
A coworker told me a story working at a med dev company that made wheelchairs. They would sometimes disposition them as "discard/trash." One day they receive a complaint and the serial number from the device was one of the ones they threw away. someone had climbed into the trash and retrieved the wheelchair and sold it on eBay. That was an interesting investigation.
 

Tidge

Trusted Information Resource
#15
And how do you know it is not your device without investigating? Because the complaint intake says so? If the complaint was directed to you and it says it is not your device, then an error was made. Was the error in directing the complaint to you? Or was it in the description of the device?

Tell me about it.
Sorry, but I'm not going to disclose information about specific customer complaints, even obliquely. Our intake group has scripts which are followed when taking complaints, and in the course of recording information provided during the intake the record is obvious that the device is not one of ours. we are obliged to take complaints. It is not the fault of the medical device manufacturer if a user incorrectly calls our hotline.
 

Watchcat

Trusted Information Resource
#16
Certainly do not expect disclosure! The questions were rhetorical. Or maybe Socratic. In any case, you know your company's system; I don't. What I know is what is commonly seen in the industry.
 

Tidge

Trusted Information Resource
#17
Fair enough. In my systems we distinguish between intake and investigation. Our intake scripts are rather comprehensive, and we have had to followup specifically for answers to questions were not provided... but we still don't consider this to be an investigation.
 

Tidge

Trusted Information Resource
#19
I'm reading the latest comment as a directed jab (having edited text of mine, removing context, implying some ambiguity in what my team considers to be an investigation), perhaps this is not what was intended.

In our system, there is no need for clarification because we have establish by procedure the difference between intake and investigation. It really isn't fair to have edited my reply to leave the implication that there is something subjective about what we do as an investigation.

If there is a point you are trying to make it may be clearer using original text rather than resorting to a découpé of attributed posts.
 

Ronen E

Problem Solver
Staff member
Moderator
#20
The word "intake" doesn't appear in part 820. The verbs "receive", "review" and "evaluate" are used in 820.198, mostly prior to "investigate" in the prescribed process.

I think that in addressing a regulation it's always best to start with the actual text of the regulation, and wherever a pivotal term is not explicitly defined in the regulation try to deduce its correct meaning from the regulation text (first the specific section, then expanding to the subpart, whole part and last, other relevant parts). Failing that, it's up to the Manufacturer to state definitions in their SOP and follow them consistently.
How can a structure make sense when the foundations are lacking?

Added in edit: This is not intended at anyone here in specific.
 
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