FDA Registration and listing weird situation

[katastic2908]

Weird situation that I could use some guidance on.
We are a contract manufacturer for a company. We manufacture a finished good device ready or distribution. Labels and all. We did not develop any of it.

Our customer, the spec developer isn't registered and listed, at least not currently. We are registered and have them listed.

We aren't sure what our customer is doing or why they aren't registered and listed and they keep avoiding the question. In the past it appears they have registered and listed the device and have a cleared 510k.

Questions
1. If we continue to manufacture these devices and they never register and list them, what sort of liability do we have? Say if they were to sell them on ebay or whatever.

2. If they haven't registered or listed them, do we have to? Let's say for example they aren't selling them anymore but are having us manufacture a few devices to finish out our contract.

3. Let's say for another example a company asks us to contract manufacture a thingy for them, if they don't tell us it is a medical device (let's say it isn't obvious) how would we know to register it. (I'm assuming we wouldn't know). I honestly don't know if this would ever happen, it seems pretty far fetched but I was just asked this question.

4. As the contract manufacturer, if I know their labeling is wrong or outdated, am I obligated to point that out to them?

 

[indubioush]

Do you also distribute the devices, or do you ship them to the customer you are referring to?
Does your company name appear on the label as the entity who manufactures the device for the legal manufacturer?
Have you been audited by the FDA?

 

[katastic2908]

We do not distribute. Only ship to the spec developer. Our name is nowhere on the product. We have not been inspected by the FDA yet.

 

[indubioush]

Does the device label state anywhere "investigational use only" or similar? It could be that the device is not being distributed to customers and they are currently working on developing the product. Or it could be that they are exporting the device to a different country. There should be a written agreement and adequate communication between you and the customer so that you know the development stage of their product and the timeline for completing activities such as process validation. It appears that this communication is not taking place. Do you have someone who had medical device experience at your organization? Many contract manufacturers add a statement on the label that a product is "Not for Human Use." They will keep this statement on the label until their customer presents evidence that the device may be used clinically or distributed.

Have you read the labeling regulations? CFR - Code of Federal Regulations Title 21
"(c) Where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such device; such as, "Manufactured for ___", "Distributed by _____", or any other wording that expresses the facts. "

 

[indubioush]

Also: Reporting Allegations of Regulatory Misconduct

 

[Haresh]

Hi,
We are contract manufacturer for OEM device as per their specification and OEM situated in US , having their 510k. Can anyone tell me how to add OEM facility and device information in our FURLS account. I have gone through the guidance but could not find the exact procedure for adding OEM facility in our device listing .
Request to you please guide me for the same.