Reply requirements to satisfy 21 CFR 820.198(e)

I

ISO tired

#1
The FDA is very vague on when it is necessary to respond to a complainant under clause 820.198(e). Approx. 90% of our complaints concerning adverse situations, after investigation are usually because of Doctor misuse i.e. over bending, wrong size. Our inserts are very thorough about the device usage.

The problem is when you do reply to a complainant with the findings, the physician does not like the results, which leads to customer satisfaction issues.

Any thoughts if it is truly a requirement to reply to a complainant concerning your findings? Especially if there is no explicit request for the results.
 
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M

MIREGMGR

#2
Re: Reply requirements to satisfy 820.198(e)

21CFR820.198(e)(8) does say that if you do respond, you must keep a record of the response. Other than that, there is no requirement in 21CFR820.198 to respond to the filer of a complaint.

However, it's notable that you have had enough complaints to be able to characterize ~90% of them as due to doctor misuse. The FDA, it seems to me, is very clear in the overall context of the QSR that device makers are obligated to take action in response to complaints about adverse events in such a manner as to cause fewer adverse events in the future, whatever the basis for the complaints. See for instance Chapter 15 "Complaints" of "Medical Device Quality Systems Manual: A Small Entity Guide", which capsulizes the FDA's guidance stance.

Based on the sparse description of the situation that you've given us, my inference would be that in some manner, your Instructions for Use--which you describe as very thorough--are nonetheless not effective.

It's conceivable that at some point an adverse event might be reported to the FDA as a complaint, and they might decide to inspect you and review your complaint records...and perhaps based on numbers of complaints, your analyses of each one, and whatever changes have or haven't been made to change the factors found in your analyses to have been responsible, it's conceivable that they might deem your device to be not effective. Effectiveness of course is a cardinal mandate for devices, so that would lead to bad things.

Thus I would suggest that, while you aren't legally required to respond to doctors who complain to you, you might want to make changes and then do some documented A/B clinicals, iterating until you achieve a substantive improvement, so that you have evidence that you've addressed the situation.

(I'm also surprised that your sales/marketing people aren't screaming that something needs to be done to avoid future adverse event complaints and unhappy doctors, but that's an off-topic direction in this forum.)
 
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yodon

Staff member
Super Moderator
#3
Re: Reply requirements to satisfy 820.198(e)

I believe MIREGMGR nailed it. I just want to add that this also 'exposes' a possible weakness in your Management Review process. If these complaints are chronic and this information is not being raised and discussed at the management level, your quality system is probably not working as it should.
 

Ajit Basrur

Staff member
Admin
#4
The FDA is very vague on when it is necessary to respond to a complainant under clause 820.198(e). Approx. 90% of our complaints concerning adverse situations, after investigation are usually because of Doctor misuse i.e. over bending, wrong size. Our inserts are very thorough about the device usage.

The problem is when you do reply to a complainant with the findings, the physician does not like the results, which leads to customer satisfaction issues.

Any thoughts if it is truly a requirement to reply to a complainant concerning your findings? Especially if there is no explicit request for the results.
How about additional labeling instructions on the insert / label - will that help you as Preventive Action ?
 
D

DeviceMaker

#7
The only number raised is the 90%. If they have sold 100,000 units, with 10 complaints, 9 of them being doctor mis-use, I would recommend keeping the current instructions, etc... If they have sold 1,000 units with 100 complaints, 90 of them being doctor mis-use, I would recommend a change. All depends on the actual data. I know 90% seems high so it jumps out and makes people think that a reaction is needed, but it should only lead to further questions to get to the real numbers. I hope this helps. :2cents:
 
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