An Insight into the Top 3 Misconceptions About Medical Device Labeling

Medical devices belong to a very huge and complex field. These devices can range from anything between a thermometer and a pacemaker.
Have you ever thought once the designing and developing a new medical device is over? You can spend a bunch of time learning what the design controls are and how to apply them.



Here we have listed three most common misconceptions about medical device labeling.

• Medical Device Labeling is Simply a Label on the Device

Before we continue further, this major misconception needs to be cleared up. 
Medical device labeling is not simply the label on your device.  When we discuss labeling, it is all about the label on the pouch or box etc. It is also about the instructions for use.

1. Labeling is more about describing the following:
2. Instructions for use and any other information that relates to identification and technical description.
3. Envisioned purpose and proper use of the medical device.
4. Excludes the shipping documents.

The device labeling is important. It is not only about copying of the matter and swapping out the name. This should not be left to be done at the very end of the project.

• Helps You to Copy the Predicate Device Labeling

Another misconception that people have is that our device should closely match the predicate device when we’re submitting a 510(k).  A Premarket Notification [510(k)] is a premarketing submission made to FDA that demonstrates that the device to be marketed is safe and effective. A device that has recently been cleared under 510(k) is usually used as a predicate device. Mostly people assume that they can swap in their device name and take the predicate device labeling.
However, it is not easy. When you want to design your device labeling, you need to certainly start with the predicate device label.
You need to be sure that you’re linking your label to the risk management. If you’ve identified any hazardous situations or harms that have not been mentioned on the predicate label, there is need to make sure that you include them on yours. 

• The Address on the Labeling is Where the Device is Made.

Another misconception is that the address on the medical device labeling is where the device has been physically manufactured. 

In present world, various medical devices are being manufactured by contractors across various corporate locations.  With so many locations involved, which one goes on the labeling? That depends on where are you selling your device?

It means that you can put the company’s address on the label and not the contract manufacturer’s, if you clearly state it’s manufactured for you.

Is 510(K) necessary for all medical devices?

There is no need for all the devices to go through a 510(K) process. Devices that pose the least risk to the user do not need 510 (K).
However, medical device labeling is more than the label on the device, you can’t just copy the predicate device labeling, and that the address on the labeling depends on where the device is manufactured and sold.

1. The medical device should be fit for its envisioned use
2. It should be properly packaged and clearly labeled
3. It should carry the name and registration of the manufacturer as well as the listing forms are required for devices with the FDA
4. It should be manufactured in accordance with the established requirements, expect in the case of a few Class I for which few records keep requirements or general files will suffice.

Hope this article post must have cleared your misconceptions about the medical device labeling.

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