Complaint Handling Under QMSR

[Chrisx]

The FDA has a lot of leverage on contract manufacturers at inspections in the form of 438's and warning letters. The QMSR makes no distinction between manufacturers and contract manufacturers. The complaint form we have isn't very difficult or cumbersome to fill out, so it really isn't a lot of additional labor. The good thing is that FDA guidance "Medical Device Reporting for Manufacturers" makes it clear that contract manufacturers are excluded from MDR reporting as long as they meet specific requirements. That makes the complaint file much simpler then an OEM would maintain. Also, I don't maintain a risk management file per ISO 14971, as I firmly believe this must be maintained by the OEM. This also makes a complaint file relatively simple.

 

[LUFAN]

The FDA has a lot of leverage on contract manufacturers at inspections in the form of 438's and warning letters.

I believe what @Tidge is implying is that unless you are a Finished Device Manufacturer, you're not FDA registered and if you're not FDA registered, FDA generally is not going to know you exist and/or being paying you visits without cause. That said, if the Legal Manufacturer has a quality agreement with a CM, and said agreement specifies that Complaint Handling is the responsibility of the Manufacturer, the CM has no complaint responsibility. It's my experience the CM still has a Complaint Procedure, but it's generally for awareness and to forward any information to the Manufacturer. If the CM, also markets the same device under their own brand, that's completely different.

 

[Chrisx]

Agreed, if you are not a manufacturer as defined in the QMSR, then you don't have to comply with the complaint requirement or any other requirement in the QMSR.

"Manufacturer means any person who designs, manufactures, fabricates, assembles, or
processes a finished device. Manufacturer includes, but is not limited to, those who perform the
functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or
specification development, and initial distributors of foreign entities performing these functions."

 

[Parul Chansoria]

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:

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.

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.

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:



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:

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?

@LUFAN
You've certainly delved deep into the regulatory intricacies surrounding complaint handling in the medical device industry, particularly in the context of the proposed changes under the Quality Management System Regulation (QMSR).

Whenever the regulatory bodies implement any kind of harmonization, an inconsistency, an overlap or applicability, non applicability concern is bound to arise.

I see a simple way to address this: Define the scope of complaint as per the FDA and as per ISO 13485, which you have already done. See which one has a broader scope, and implement that consistently across the company. I suggest this especially for complaints, since an effective complaint handling system is the key to customer satisfaction, custom retention, and offering data to drive changes.

Hence, a little extra work will go a long way. Having said that, whichever way you choose to go for implementation based on interpretation, ensure that the chosen path is well justified in terms of the device risk, nature of the complaint, and identified root cause.