Cons of having 3rd party labeler of medical device issue the UDI.

[Quabity Assurance]

I work for a small start-up company and we are moving towards submitting for our first 510(k) clearance. We will own the design controls, and manufacture the device, but then send the device to a contract manufacturer to complete final assembly, packaging, and labeling activities. The contract manufacturer will send the packaged device to the sterilizer. Following sterilization, the device will be returned to my company and we will handle distribution. The labels will reflect my company's information.

I'm currently discussing UDI requirements with the owners of the company. They are considering having the contract manufacturer issue the UDI. Does anybody have experience allowing a contract manufacturer handle their medical device's UDI? I am concerned that if we were to use a new contract manufacturer down the line, it will become a bit messy to transfer the UDI. I have limited experience with UDI, but I seem to remember that there were some restrictions in creating a new UDI for a device that had already been issued a UDI. I am also concerned that the UDI would be linked to the contract manufacturer's DUNS number, rather than my company's DUNS number. Could this cause any confusion in regards to complains, medical device reporting, advisory notices, recalls, etc.?

Or would it be a better option to allow the contract manufacturer, who has a lot of experience with UDI, control our device's UDI.

I want to provide the owners with clear pros and cons. Any insight would be greatly appreciated. With the current government shutdown, I am not confident I would be able to get a response from the FDA regarding these questions.

 

[yodon]

Off the top of my head, I can't think of any actual benefits to having the CM handle all that. If you just don't have the experience, I would expect they could help guide you through the process. (And there are some good folks here in the Cove that would likely help as well!) I think it would be in your best interest in the long run to take it all on. After all, your company IS accountable for it all.

 

[Nichole F]

As the labeler, it is your responsibility to assign the UDI. You cannot delegate this responsibility to your contract manufacturer. They will not be able to load the UDI into GUDID under your DUNS number without access to your FDA GUDID account. There are third parties that will manage your UDIs if you are not comfortable doing so yourself or there are plenty of people here in the Cove that can guide you. It is much less daunting than you think once you understand the process

 

[EmiliaBedelia]

I emailed the GUDID support team 2 weeks ago and got a response the same day. The DICE/GUDID/CDRH portal team is very helpful.

You absolutely need to manage your own UDIs. It's not actually very difficult, especially if you only have a few devices - you can even directly update them in GUDID yourself without setting up another system. UDI is basically set it and forget it - you assign it and then you never have to worry about it again (until you release a new device, or make a change that requires a new UDI)....

If you're concerned about inexperience and your CM does have the experience, consult with them for guidance on setting it up and getting your own DIs.

 

[Quabity Assurance]

Thank you yodon, Nichole F, and EmiliaBedelia! I absolutely agree and I am trying to get the owners to understand why it's best that we manage the UDI process ourselves, but they aren't familiar with the medical device regulations or UDI, so it has been a bit challenging. And of course, I wanted to see if there were reasons to allow the contract manufacturer to handle the UDI, as I could have been interpreting the requirements incorrectly or have been pushing for controlling the UDI the only way I've known to do it. I don't want to be the person that says "but we've always done it this way" . I feel more confident about my push to manage our UDIs after your consistent answers in your replies. I set up a meeting for next week to perform an overview of the UDI system, so hopefully once they have a better understanding and grasp on what a UDI is and who typically manages it, then hopefully they agree to keep it in-house.