Complaint Handling Under QMSR

[LUFAN]

So I had a "Shower Thought" the other day that I'm trying to check if it's insane or if this is going to be a fundamental shift in Complaint Handling application under the proposed QMSR. This may come across as rambling, but there are a few moving pieces here.

We know that under the QSR the following is a complaint:

(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. - 21CFR820.3(b)

It's always been my understanding, that distribution, coupled with the following definition from 21CFR807, refers to a device that is commercially offered for sale on the market.

Commercial distribution means any distribution of a device intended for human use which is held or offered for sale - 21CFR807.3(b).

That said, if you were manufacturing a device that had not yet been released on the market, Complaint Handling would not apply. Further, Complaint Handling under the QSR has been the responsibility of the Manufacturer, unless written agreements state otherwise, per the language in 820.198.

(a) Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. - 21CFR820.198(a).

Now let's get into the application of the QMSR. We know the FDA is proposing to amend the CGMP to incorporate 13485 and add additional requirements on top of it.

They state in the definition section:

We have reviewed the definitions in ISO 13485 to determine their suitability for FDA's purposes. We find that most of the definitions in Clause 3 are acceptable; thus, unless identified in this section, we are not proposing any modifications to the terms and definitions in Clause 3 and are proposing to remove the correlating terms and definitions from the current part 820.

We are retaining the majority of the definition of “rework”; however, we are proposing to remove the term “device master record (DMR)” (§ 820.3(j)) from the regulation.

We are retaining without change the terms and definitions for “component” (§ 820.3(c)); “finished device” (§ 820.3(l)); “human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device” (820.3(bb)); “design validation” (§ 820.3(z)(2)); “remanufacturer” (§ 820.3(w)); “nonconformity” (§ 820.3(q)); and “verification” (820.3(aa)) because these terms are necessary for implementing part 820.

It is noted that Complaint is NOT one of the terms the FDA has identified to retain from the QSR. I was curious to see if "Finished Device" was going to be the out here, but that does not appear to be called into 21CFR820.198 as a distinction between a device and a finished device. So that then points us to the 13485 definition of a Complaint, which states:

“written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a medical device that has been released from the organization’s control or related to a service that affects the performance of such medical devices.” - ISO 13485:2016 3.4.

It's been my understanding if you were both ISO 13485 certified and compliant with the QSR, based on the language in section 0.1, you could adopt the FDA definition of a complaint and go with it. I've not been challenged on that in my entire career, as both a manufacturer and a contract manufacturer, however, my frame of reference is usually FDA-based.

So in summary: If the FDA is choosing to incorporate the 13485 definition of a complaint and no longer retain theirs, does that infer that the FDA will expect Complaint Handling to be performed on devices no longer in the organization's control too? Could you realistically get a complaint from a vendor and/or a customer? Examples off the top of my head, mislabeled devices sent to a supplier for service? CMs getting SCARs from a Customer. I can see the cases in some scenarios where complaint handling may already be occurring per the 13485 definitions, but I can see plenty where organizations may not have any complaints (QSR only contract manufacturers) and will in the future. Any other interpretations of the above?

 

[Chrisx]

It's hard for me to imagine a contract manufacturer that has no process for complaints. What would they do with returns? Just ignore them and not conduct any investigation. I think that would hardly be acceptable to the customer. I suspect most contract manufacturers already have a complaint process. Certainly, I think it would be in the best interest of the contract manufacturer to have a complaints process.

 

[LUFAN]

It's hard for me to imagine a contract manufacturer that has no process for complaints. What would they do with returns? Just ignore them and not conduct any investigation. I think that would hardly be acceptable to the customer. I suspect most contract manufacturers already have a complaint process. Certainly, I think it would be in the best interest of the contract manufacturer to have a complaints process.

It's been my experience that's always been NCMR'd and the investigation done there. Specifically because quality agreements usually dictate that complaint handling is the responsibility of the customer. 21CFR820.198 specifically says "Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit." Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device.

 

[Chrisx]

I'm not sure we would have fared well in our last FDA inspection without a complaint process. We do open an NC for all returns, but we also have a complaint file. I definitely would not feel comfortable going into an FDA inspection with no complaint files. I suppose it depends upon your risk tolerance. We are a contract manufacturer of finished devices, so by the definition cited in 21CFR820.198, we are required to have complaint files.

 

[FRA 2 FDA]

This is an interesting thought/question. I unfortunately can't contribute but wanted to say I'm glad I'm not the only one who has such shower thoughts!

 

[Ed Panek]

Is the device released under investigation (IDE)? If so all lay users are consented and complaints are handled via IRB/FDA depending on complaint level and seriousness.

 

[LUFAN]

Is the device released under investigation (IDE)? If so all lay users are consented and complaints are handled via IRB/FDA depending on complaint level and seriousness.

My frame of thinking was that of a commercially saleable/authorized product line, but if a Contract Manufacturer was manufacturing a finished device for the Manufacturer, and prior to the individual devices' release. Such that if that CM needed to ship the device to a 3rd party for say sterilization, and the 3rd party noticed an issue with a label (for example). I assume that device is considered outside the organization's control and could feed the complaint handling process of the CM under that new definition. Where prior, my experience is that FDA would have generally never considered that a complaint at the contract manufacturer level yet alone before a batch release (this is assuming there's a quality agreement in place between the CM and Manufacturer).

 

[Ed Panek]

My frame of thinking was that of a commercially saleable/authorized product line, but if a Contract Manufacturer was manufacturing a finished device for the Manufacturer, and prior to the individual devices' release. Such that if that CM needed to ship the device to a 3rd party for say sterilization, and the 3rd party noticed an issue with a label (for example). I assume that device is considered outside the organization's control and could feed the complaint handling process of the CM under that new definition. Where prior, my experience is that FDA would have generally never considered that a complaint at the contract manufacturer level yet alone before a batch release (this is assuming there's a quality agreement in place between the CM and Manufacturer).

Ok. I see. I think fda has binary vision. In your control vs not in your control. Unless the other party is approved for product release this seems like internal control so use NCR or similar process or a supplier kpi or similar?

 

[Chrisx]

If the nonconformance process contains all the elements required for a complaint per 21CFR820.198, then it could be possible to utilize the nonconformance process to manage complaints. However, I would think that every nonconformance would require fields for the required complaint information (complaint date, UDI, name/address of complainant, etc), otherwise these critical elements might not get documented. This to me would seem to be cumbersome. For this reason, we have a separate form to document the required elements of a complaint file, rather then documenting it in the nonconformance.

 

[Tidge]

So in summary: If the FDA is choosing to incorporate the 13485 definition of a complaint and no longer retain theirs, does that infer that the FDA will expect Complaint Handling to be performed on devices no longer in the organization's control too? Could you realistically get a complaint from a vendor and/or a customer? Examples off the top of my head, mislabeled devices sent to a supplier for service? CMs getting SCARs from a Customer. I can see the cases in some scenarios where complaint handling may already be occurring per the 13485 definitions, but I can see plenty where organizations may not have any complaints (QSR only contract manufacturers) and will in the future. Any other interpretations of the above?

Practically: My thinking is that the FDA would expect the business marketing the device to have the complaints process, and that contract manufacturers would be handled via supplier corrective actions (SCAR) from the business that got the complaint. Put another way: if the Contract Manufacturer isn't marketing the widget as a medical device, there is no reason for the manufacturer to implement a process required for medical device manufacturers.

I should write: I can imagine a medical device manufacturer trying to impose a complaints handling process on a CM. But if I was making an external power supply (for example) that happened to be shipped along with a medical device, and my company got a "complaint" about it, I'd direct the complaint to the medical device manufacturer. This isn't to say I'd ignore whatever information came in (as a CM), just that for medical device complaint handling, that may literally be "not my my job." I have seen a medical device manufacturer try to pin lots of blame on suppliers (including CMs), but it was the medical device manufacturer that lost almost all its business and faced regulatory penalties, not the suppliers.

The FDA isn't going to have much (if any leverage) over some (most?) contract manufacturers, but they will have a LOT of leverage over medical device manufacturers.