When you first start designing and developing a new medical device, you spend a bunch of time learning what design controls are and how to apply them. You spend a bunch of time learning around risk and how to mitigate it.
And you assume that when it comes time to create the labeling for the device, it’s going to be easy.
After all, how hard can it be compared to the designing your device?
Let’s dive into 3 of the most common misconceptions about medical device labeling.
1. Medical device labeling is just the label on the device.
Before we go any further, we have to get one major misconception cleared up.
Medical device labeling is not just the label on your device.
When we talk about labeling, we’re talking about the label(s) (on the pouch, on the box, etc.) AND the instructions for use (IFU).
Most people think that medical device labeling is just the label on the device or box and don’t think about the IFU.
According to the FDA, labeling is..
“all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article' at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce. The term 'accompanying' is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc.”
And ISO 13485 defines labeling as...
“label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents”.
While the device label is important, it’s not the extent of medical device labeling.
Don’t leave labeling to the very end of the project. It’s not just a matter of copying what the other guys did and swapping out the name.
Which brings us to the next misconception.
2. You can essentially copy the predicate device labeling.
One of the things that we’re all told, is that our device should closely match the predicate device, when we’re submitting a 510(k).
Most people assume this means they can take the predicate device labeling, swap in their device name and call it good.
Unfortunately, it’s not that easy.
When you’re designing your device labeling, you can certainly start with the predicate device label. It will give you a good starting point for what warnings and cautions you might need to include.
But you can’t stop there.
Your labeling is part of your design outputs and needs to be treated as such.
You also need to make sure you’re linking your label to your risk management. If you’ve identified hazardous situations or harms that aren’t mentioned on the predicate label, you need to make sure you consider including them on yours.
In some cases, the predicate device was created years before your device and new information about hazardous situations and harms may be available.
As for the rest of the labeling, specifically the IFU, don’t assume that you can just swap out the information on how to use the predicate device with how to use yours.
You need to make sure you’re doing your due diligence on how easy the IFU is to read and understand.
3. The address on the labeling is where the device is made.
One final misconception is that the address on the medical device labeling is where the device is physically manufactured.
In today’s world, more and more medical devices are being made by contract manufacturers or in a different corporate location.
With all of these locations involved, which one goes on the labeling? It actually depends on where you’re selling your device.
Under 21 CFR Part 801.1, the FDA requires that the label “shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.”
And that if 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.”
That means that you can put your company’s address on the label, not the contract manufacturer’s, as long as you clearly state it’s manufactured for you.
But what about the rest of the world?
You very likely need to have multiple addresses on your label if you’ve got a device being sold in the EU or other countries.
The MDD requires the name and address of the manufacturer and the name and address of the authorized representative.
In Japan, you’re required to have the address of the Marketing Authorization Holder (MAH) Designated Marketing Authorization Holder (D-MAH) on the label.
Depending on where your device is being manufactured and sold, you’re likely going to have addresses other than the manufacturer on your label.
Clearing Up the 3 Misconceptions about Labeling
Now you know that when it comes time to create the labeling for the device, it’s not going to be as easy as you thought.
But it’s not going to be all that bad either.
Because you know that medical device labeling is more than the label on the device, that you can’t just copy the predicate device labeling, and that the address(es) on the labeling depend on where the device is manufactured and sold.
Clearing up those 3 common misconceptions is going to make designing labeling that much easier.