UDI (Unique Device Identification) for Convenience Kits with several options



:bigwave:Hi all,

I'm working for a manufacturer of diagnostic medical devices (class II in US). We offer convenience kits consisting of a basic device (=MD) that works together with different sensors (also MD's). The sensors are AND/OR options packaged according customers choice.

Now we have to implement an UDI system and we are discussing how to handle the different options.
Do we need only one UDI, although not all options are shipped or do we need and UDI for each possible combination of options?
Is there any class III manufacturer who has experince how to handle it?


Quite Involved in Discussions
FDA issued a letter a few weeks ago stating that implants sold non-sterile and sterilized at the hospital must have a UDI with each implant. A one year extension was given for this new regulatory requirement. Essentially FDA decided that these devices are not convenience kits, even though they are multiple medical devices packaged together for the convenience of the user. I would be careful applying the convenience kit exemption. At this point, I can see no way of knowing what is eligible to be a convenience kit and what is not a convenience kit.

Laura S

I have submitted questions to the FDA UDI Help desk on a similar issue related to convenience kits. One question they asked me was what was the product code of each of the components of the kits. You may want to determine the FDA product code for your items and ask the UDI to give a review to your proposed approach.

A conservative approach would be to have a separate UDI for each combination of kit component so that it would be easy to track individual kits in the event of a downstream recall. Since FDA hopes to use UDI for post-marketing activities, separate UDIs would allow the best statistical review of your separate product lines down to the "SKU" level.

Another consideration for risk management purposes - remember your design controls have to speak to this - is whether or not the kit components would every be separated for storage at the hospital or end user location. In that case, where separation is possible or probable, your company may wish to label individual components.

As an illustration, companies that are making combination product kits that contain PFS syringes are attempting to make decisions that answer all of these questions now. The answers they come up with for their product line may be different than what other manufacturers of combination products may determine, but each manufacturer must justify their approach in their Design History Files for future agency review.