Classification of Complaints from Beta Sites - Complaints Definition per QSR 820.3

shimonv

Trusted Information Resource
#1
Hi all,
Below is the definition of Complaint from QSR 820.3:
"Complaint means 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."

Below is the definition of Complaint as appears in ISO 13485, section 3.4:
"written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device that has been placed on the market."

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My question is: how do you process input from a beta site? Do you treat it as a complaint or do you use internal R&D SOP process?

To make it more interesting, would you treat it differently if the beta site is for a product with a previous regulatory clearance (i.e. modification for an approved product) as apposed to a site for validation of a novel feature.


Thanks,
Shimon
 
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Stijloor

Leader
Super Moderator
#2
Re: Classification of Complaints from Beta Sites - Complaints Definition per QSR 820.

A Quick Bump!

Can someone help Shimon?

Thank you very much!!
 

yodon

Leader
Super Moderator
#3
Re: Classification of Complaints from Beta Sites - Complaints Definition per QSR 820.

Well, I'll toss in my thoughts but it's not my area of expertise so maybe someone will give a more definitive answer.

I guess my first question is what's the scope of the beta site / testing? Could this cause harm?

We often act as an Independent V&V company and we're good at rooting out problems before the product hits the market. To the best of my knowledge, none of the issues we dig up (on yet-to-be-marketed products) are documented as complaints (per the regulatory/standards definition). They are all handled in R&D; but they ARE handled under Design Change Controls.

My second question would be to wonder why you wouldn't want to handle them as complaints. It might provide a good pathway to document and manage the changes. Not all complaints are required to be reported.

Finally, regarding the plot twist (changes to a marketed product being beta tested), it certainly gets trickier. If the complaint has nothing to do with the changes but reveals an issue with the baseline (marketed) product, it would probably be a good idea to document it as a complaint. You may need that to support notifications to existing customers. Otherwise, it may fall back into the category discussed above.
 

sagai

Quite Involved in Discussions
#4
Re: Classification of Complaints from Beta Sites - Complaints Definition per QSR 820.

Well, when we look at the scope of the CFR it says:
(2) The provisions of this part shall be applicable to any finished device as defined in this part, intended for human use, that is manufactured, imported, or offered for import in any State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.
so for me the inputs coming from the beta testing of a proposed device are more like feedbacks for product management/engineering rather than a complaint.
The other thing is if it would be considered as a complaint and the investigation may identify safety related extents than how would you fulfil the reporting requirements?

Actually, I agree with Yodon. It could be a complaint if relates to the previously marketed baseline deficiencies. Than beta testing could be another source of complaints.

Cheers!
 

shimonv

Trusted Information Resource
#5
Re: Classification of Complaints from Beta Sites - Complaints Definition per QSR 820.

Thanks guys,
Few pointers of my own:

1. The phrase "Finished device" is not clearly defined in QSR:

Definition according to 820.3(l): "Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized."

2. To me, the more significant phrase is taken out from the definition of complaint according to 820.3(b):
Complaint means 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 phrase ?released for distribution? is mentioned 4 more times in QSR. Section 820.160(a) says: ?Each manufacturer shall establish and maintain procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed and that purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution.?
The terminology here clearly implies that complaints are related to products in the post-production phase.

3. This is what I found in QSIT, which is FDA guide to inspection of quality system:

"[?] Manufacturers may use their routine post-production change control procedure for pre-production design changes. However, most post-production change control procedures may be too restrictive and stifle the development process. Firms may use a separate and less stringent change control procedure for pre-production design changes."

What they are saying, and I agree with them, that its better to have a separate process for controlling changes during design & development phase.

Cheers,
Shimon
 

Highground

Involved In Discussions
#6
Re: Classification of Complaints from Beta Sites - Complaints Definition per QSR 820.

Well, I'll toss in my thoughts but it's not my area of expertise so maybe someone will give a more definitive answer.

I guess my first question is what's the scope of the beta site / testing? Could this cause harm?

We often act as an Independent V&V company and we're good at rooting out problems before the product hits the market. To the best of my knowledge, none of the issues we dig up (on yet-to-be-marketed products) are documented as complaints (per the regulatory/standards definition). They are all handled in R&D; but they ARE handled under Design Change Controls.

My second question would be to wonder why you wouldn't want to handle them as complaints. It might provide a good pathway to document and manage the changes. Not all complaints are required to be reported.

Finally, regarding the plot twist (changes to a marketed product being beta tested), it certainly gets trickier. If the complaint has nothing to do with the changes but reveals an issue with the baseline (marketed) product, it would probably be a good idea to document it as a complaint. You may need that to support notifications to existing customers. Otherwise, it may fall back into the category discussed above.
Has anything changed since this tread started. We release software updates to beta sites only for several months for our active devices and when we have a reported complaint related to the change, a bug in the software we have been treating it as a complaint for only those sites. Fix will be needed to correct the bug issue. I have suggested that we put this into our procedures. Any suggestions on this? Maybe we carry on as is?
 
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