GUDID Labeling and Levels of Packaging

J

Jeffers

I know there have been quite a few "here is my packaging, is this what you would do?" type questions, and, well, mine is no different. I am hoping someone may be able to provide a recommendation on the best way to implement the UDI labeling requirement given my current packaging.

I manufacture and package a class II dental medical device. Our device is a single use item which does not require processing before use, and therefore will not require direct labeling. It is not supplied sterile. Our medical device is supplied in 4 different sizes, all share identical chemical makeup. 5 pieces of material are placed into a re-sealable pouch (all are the same size).

When a customer receives our product, they receive one box with 4 pouches of material; 1 pouch of small sized material, 1 pouch of medium sized material, 1 pouch of large sized material, and 1 pouch of extra large sized material. Each pouch contains 5 individual medical devices. The devices are intended to stay in the pouches within the box until they are used.
To make this more clear, here are the contents of 1 box:
- 1 pouch of small material, the pouch containing 5 individual units
- 1 pouch of small material, the pouch containing 5 individual units
- 1 pouch of small material, the pouch containing 5 individual units
- 1 pouch of small material, the pouch containing 5 individual units

Here is how I intend to choose and implement the UDI system:
DI of individual unit of small: DI= G10, this is a base unit of this product
DI of individual unit of medium: DI= G20, this is a base unit of this product
DI of individual unit of large: DI= G30, this is a base unit of this product
DI of individual unit of extra large: DI= G40, this is a base unit of this product
DI of pouch containing 5 small units: DI=G11, this DI record will indicate 5 units of G10
DI of pouch containing 5 medium units: DI=G21, this DI record will indicate 5 units of G20
DI of pouch containing 5 large units: DI=G31, this DI record will indicate 5 units of G30
DI of pouch containing 5 extra large units: DI=G41, this DI record will indicate 5 units of G40
DI of Box: G02, this DI record would include 1 unit of each of the following: G11, G21, G31, G41

This leads me to my two questions:
1) Am I able to use the definition of “convenience kit” in this instance? My items do not require reprocessing if they are not used at the time of a procedure.
a. If this is the case, then I believe I would be able to apply a UDI label on the box of my product, but the individual pouches of the product will not require UDI labeling.

2) Customers are able to customize the pouches that are included in their boxes. For instance, some customers might choose to purchase 2 pouches of medium devices and 2 pouches of extra large devices. I was hoping to utilize the same DI for a box that was previously designated (G02). When I submit the DI to GUDID, will it still be accurate that I am including 4 of the following items, G11, G21, G31, and G41 in some combination (it might be 1 of each, or 2 of two different sizes, etc. but the combination would add up to 4 pouches)?

Thank you in advance for your assistance, and let me know if anything needs more elaboration.
 
Q

QA-Man

I think your problem is one that the agency is just beginning to consider in any depth. The good news is it looks like you have time.

The FDA has extended the deadline for "collections of two or more different devices packaged together in which the devices in the package are not individually labeled" until 2018 (broken link removed)

They also released a draft guidance very recently concerning convenience kits bearing a UDI but not the devices which they contain here

You could wait until closer to 2018 to see what happens. I just labeled our kits with the UDI and none of the constituent products.
 
J

Jeffers

Hello QA Man, and thank you for your reply. I received the FDA notification about the extension for combination products last week, and I also have their additional guidance on their interpretation of "convenience kit". I agree with your interpretation, and just wanted a second opinion confirming this.

I wrote up a brief internal memo on why our product in its current packaging fits within the FDA's own definition of "convenience kit", and therefore has an extension until the 2018 deadline.

This website is great.
 
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