Rule for Complaint Definition - 21 CFR Part 820.3(b)

Aphel

Involved In Discussions
#1
Hello everybody,

At the moment we have a lot of discussions at our site regarding the definition of a complaint.

It is clear - there is the definition in §820.3 (b).

But the problem i have is the following:

Is it allowed the define a timeframe for handling field problems caused by the product as a complaint?
Is it allowed - for example to establish a rule, that says - only those field problems are declarated as a complaint, when they arrive within the 2 year product warranty time? (This is an idea of our management to reduce extravagant expenses)

I think this is not allowed, because you have to declare field problems caused by the product as a complaint during the whole product lifecycle - am i right?

Thank you very much for your support!

Best regards,
Aphel
 
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Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#2
Re: rule for complaint definition

Hello everybody,

At the moment we have a lot of discussions at our site regarding the definition of a complaint.

It is clear - there is the definition in §820.3 (b).

But the problem i have is the following:

Is it allowed the define a timeframe for handling field problems caused by the product as a complaint?
Is it allowed - for example to establish a rule, that says - only those field problems are declarated as a complaint, when they arrive within the 2 year product warranty time? (This is an idea of our management to reduce extravagant expenses)

I think this is not allowed, because you have to declare field problems caused by the product as a complaint during the whole product lifecycle - am i right?

Thank you very much for your support!

Best regards,
Aphel
I am not an expert in the Medical Field, but my opinion on this is as follows:

I agree with your statement of not being allowed. It seems that (even Management) would want to know failure rates during Product Life-cycles and warranty periods. That is useful data for the Organization.

How could Management improve the product's Life Cycle, if they don't track the failure rates in the field and warranty claims? Doesn't make sense to me.
 
M

MIREGMGR

#3
I think this is not allowed, because you have to declare field problems caused by the product as a complaint during the whole product lifecycle - am i right?
Yes.

If it's desired to limit the time during which complaints can result, the declared life of the product could be defined to be shorter, with appropriate communication to the customer and user of that shorter product life. For units in the field before such a shorter life was communicated, though, complaints would have to be recognized throughout the product's prior defined life.
 

yodon

Staff member
Super Moderator
#4
Still, wouldn't a complaint be a complaint even if the device is used after the defined product life?

Worst case: a product is being used after defined product life and a patient dies (not necessarily as a result of product life). The user calls it in. I don't think the company can say "well, you were using it past the defined life so too bad."

Wouldn't the complaint need to be received into the system and processed.. including, in this case, notification to FDA via MDR?

Interesting question. I look forward to seeing more discussion.
 
A

Al Dyer

#5
A complaint is just a question. The follow through on that question is the important part of a successful enterprise.

Al...
 
M

MIREGMGR

#6
Still, wouldn't a complaint be a complaint even if the device is used after the defined product life?

Worst case: a product is being used after defined product life and a patient dies (not necessarily as a result of product life). The user calls it in. I don't think the company can say "well, you were using it past the defined life so too bad."

Wouldn't the complaint need to be received into the system and processed.. including, in this case, notification to FDA via MDR?
I'm quite sure the FDA will expect an Adverse Event (as defined) to be notified by MDR no matter when or under what circumstances it occurs. The rules clearly provide for "blame" (to use a non-legal term) to be determined as a part of, or after, reporting.

Use of a labeled device other than per its labeling, except in circumstances where FDA finds the labeling was unclear or otherwise faulty, is a specific condition under which the regulatorily responsible party is not subject to FDA action.
 

Aphel

Involved In Discussions
#7
Hello!

Does anybody has experience in doing complaint handling in a similar way i described in my first thread?

Again, the question is: How long during the product lifecycle is it required to create a complaint file due to a nonconforming product in the field?

I guess, the solution our management wants to achieve - reducing the timeframe for complaint files only in the product warranty period - is under the regulatory aspect not allowed.
I think, if a manufacturer has defined a product life in the field of e.g. 10 years, then every field problem caused by the product has to be treated as a complaint per §820.198...

What do you think about it?

Best regards,
Aphel
 
P

PaulGr

#8
Hi Aphel,

I would say: during the complete product life cycle. And to react on Yodon: probably beyond that too - unless you notified all customers with 'end of life' devices.

I don't see how your management 'wants to reduce extravagant expenses'? If it is about warranty costs, that's limited by the 2 years warranty time. If it is about the costs of running a complaint department, they might consider moving to a less regulated industry? :)

Besides, complaint data is a valuable data source for product improvement and new product development (e.g. as input for the risk management process).

Cheers, Paul
 
M

MIREGMGR

#9
Again, the question is: How long during the product lifecycle is it required to create a complaint file due to a nonconforming product in the field?
Your complaint system...or more particularly that aspect of your complaint system that receives the complaint and then evaluates it (and documents the evaluation) as to whether it is Reportable to the various applicable regulatory authorities...must operate for the clearly-user-communicated life of a medical device, plus some margin.

If it's desired to have it operate for a shorter time, you should clearly communicate to your users that your device has a shorter life. That for instance could be done by stating an expiration date on the label, with whatever product life you think is market acceptable and meets your cost control goals.

It's relatively common for EtO-sterilized disposables in sterile barrier pouch packaging to be labeled with an expiration date that results in a 5 year life. It would be possible, and legal, to market such a device with a three month expiration-date. Potential customers, however, might reasonably choose not to buy such a product, because the shorter product life would be inconvenient and potentially wasteful for them.

I guess, the solution our management wants to achieve - reducing the timeframe for complaint files only in the product warranty period - is under the regulatory aspect not allowed.
Right.
 
T

tata347

#10
Yes, I agree with Paul but you haven't stated what the device is, (Class I, II,II??).

Frankly if the device is out of warranty it does not remove your liabilty or responisbility if the device is involved with an adverse effect or potential risk of the device. You still must investigate the complaint even if it is out of the warranty period; the FDA doesn't care about warranties just the patients and the safety, effectiviness and relialablity of the devices that are used.
 
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