Is Establishment Registration Necessary?

#1
I work for a very small company that develops medical products; let's call us R&D. One of our clients is Very Large Medical company, aka VLM.

Years ago, VLM hired us to adapt our core technology to one of their established product lines. They provided us with high level specifications. Over the course of development, we worked with them to develop lower-level requirements ("should the detection range be 3cm or 4?"). VLM signed off on every design document we generated and participated in all design reviews. VLM's name is on the product, they distribute the finished device, they are the only ones with field customer contact, they handle complaints, etc.

We both agreed to use a Contract Manufacturer geographically near R&D for ease of troubleshooting, etc. That CM is ISO 13485 compliant and regularly inspected by FDA. Our contract with VLM is such that they send us a PO for product and we in turn issue a PO to the CM, who ships finished product directly to VLM. The CM operates from work instructions and drawings we send them after VLM approval.

For years VLM sent a Quality Engineer to the CM to do a final check of the product before it was boxed. This occurs at the end of each work order, about 4 times a year. It always seemed superfluous to us, but hey, their name is on the label. About 4 years ago, VLM requested that we, the fine folks at R&D, conduct this inspection to save them from having to send a QE up here each time. VLM trained us to use their inspection procedure and their data upload process. The only time we interact with product is just during this inspection, a few times a year.

We are certified to ISO 13485, but have never registered our establishment with FDA because we considered ourselves a contract R&D facility, and therefore exempt.

However, VLM recently decided that we must register our establishment because:

1. By performing the inspection process for them at the CM, we are carrying out a manufacturing activity (manufacturer).

2. We may have crossed the line into specification development years ago (specification developer). (Our response is that any specification development that we might have engaged in was completed a decade ago and it seems ridiculous to register for that now).

We are VERY resistant to registering our facility. Besides the registration expense, we would need to rework our QMS to explicitly reference 21 CFR 820 requirements and also open ourselves up to FDA inspection. This seems just ludicrous because of a few hours a year of product inspection at the CM, done at VLM's direction.

I requested that VLM document that R&D is acting as their agent when conducting the inspection, thus putting the inspection under their control / QMS. I know of others who have done this. However, they are pushing back against this idea. VLM suggested that we call FDA in hopes that FDA would say registration was not necessary. That seems fraught with all sorts of potential problems.

As a last resort we could tell VLM we are unwilling to continue to do the inspection on their behalf, if that means we have to register our establishment. That's tricky though as we want to treat them well and maintain a good working relationship with them.

I'd love feedback. Does R&D need to register our establishment? If not, how can we convince VLM of this? Is there some sort of written authorization that VLM could provide us that documents we are acting as their proxy to avoid registering our establishment?
 
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indubioush

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#2
From what you describe, it does seem like you would as a Specification Consultant, which does not require registration. However, I think contacting the FDA is a good idea here. It seems that there would be no other way to convince, VLM, and if it turns out that the FDA does want you to register, then that is what you should do. A lot of the requirements in the CFR would not apply to you, and since you already have ISO 13485, becoming compliant to the CFR would be easy.

I assume you already have a quality agreement with them that defines responsibilities.
 
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