Medical Device Labeling MisconceptionsRoyal Label
In the United States, the Food and Drug Administration (FDA) strictly enforces medical device labeling to ensure that people can use these devices safely and are aware of all risks involved. Device labeling is monitored by similar agencies in countries around the world. Companies producing and selling medical devices must meet all the product label requirements.
However, there are some common misconceptions when it comes to understanding medical device labeling. And manufacturers and distributors must have all the facts so that mistakes aren’t made.
Let’s take a closer look a four common medical device labeling misconceptions:
Misconception #1: Medical Device Labeling Is Just the Label on the Device
Perhaps one of the most misunderstood aspects of medical device labeling is what information falls under the term “medical device label.” Many people mistakenly believe that only the label on the device itself is considered medical labeling. The truth is, medical device labels include the label on the device and the instructions for use (IFU) of the product.
This means that the IFU must always be taken into consideration when labeling medical devices.
Misconception #2: Copying Predicate Device Labels Is Good Enough
It is common for a new medical device manufacturer to submit a premarket notification to the FDA before being sold. The purpose of this premarket notification, also referred to as a 510(k), is so a medical device can demonstrate it is safe by showing it’s substantially equivalent to one already being sold on the market. The product on the market is referred to as the predicate device.
In simpler terms, this means that a new medical device is using a predicate device as a basis to demonstrate that it is safe. Using this logic, many people think that they can just copy the information on the predicate device label and use it as their own — not true!
While similar to the predicate, your product is still its own unique device, so its product label requirements must include any risks and hazards the predicate product may not consider. As discussed above, the medical device label must consist of all pertinent device information and the IFU. Your IFU will almost certainly be different from the predicate device’s IFU.
Do not assume that the information on a similar device being sold is reliable — it’s up to you to keep everything current.
Misconception #3: Where the Device Is Made Is the Address That Should Be Listed
When designing custom medical labels, many people believe the addresses required to be listed on the labels for consumer products is the place where the device is manufactured. The truth is, it can be much more complicated than this.
It is more and more common for the manufacturing of medical devices to be contracted out to other places than the company or corporation’s physical location that distributes it. To further complicate the matter, many companies have more than one headquarters, often located in different parts of the world. With all these other locations involved, and the address on the label not necessarily the place of the manufacturer, it leaves many people to ask: What address do I put on the medical device?
The answer to this question is that it all depends on where the device is being sold. Under the FDA, the business that manufactures, distributes, or packs the device must be listed. This address must include the street address, city, state, and zip code under most circumstances.
If a device is manufactured by a company other than that on the label, the address must include phrasing that informs the customer of the connection between companies in the manufacturing and the distribution of the device.
It is important to note that these are the requirements under the FDA in the United States. Devices being sold in other parts of the world will have different requirements for listing addresses. It’s best to thoroughly investigate all the requirements from the agencies that oversee labeling in each country that the product is being sold in.
Misconception #4: There Is a One-Size-Fits-All Medical Device Labeling
There is no single template that can be used to label a medical device. The truth is, each medical device needs a custom medical label that conveys the devices’ unique information and IFU in straightforward terms.
That’s where Royal Label comes in. We can meet all of your product label printing needs with the highest quality labels. Royal Label is incredibly experienced in medical device labeling and can provide you with customized labels to meet all the FDA or other regulatory agencies’ label requirements.
Contact Royal Label today to learn more!