Gaining FDA approval is one of the most significant milestones of developing a new medical device. There are three classifications of medical devices with different requirements and testing that are needed before your product can be cleared to go to market. So, the last thing you want is the label holding you back from getting approved.
Most product designers understand they need a label for their medical devices. But what does that entail, exactly? In this article, we’ll discuss the requirements and essential information to include in your medical device label.
Does my medical device need a label?
The purpose of a medical device label is to provide important safety information to users, including medical professionals, caregivers, and patients. In the US, medical device labels are governed by the FDA. According to the agency, a medical device is a product that “diagnoses, cures, treats, or prevents a disease or health condition, or otherwise alters the structure or function of the body.”
Additionally, the FDA considers a label to “display of written, printed, or graphic matter upon the immediate container of any article.” So, if you have a product that meets the definition of a medical device, producing a suitable label is critical for securing FDA approval.
The FDA has general labeling requirements that outline the minimum standard for medical devices. In short, a device label must include the name and location of the manufacturer, along with the intended use of the device. Adequate directions must be provided, meaning instructions that a layperson could understand and follow to use the product safely. Finally, the label can’t include false or misleading statements, and important statements must be given appropriate prominence.
Information to include on a medical device label
Fortunately, you’re not completely on your own when creating a medical device label. The FDA provides
ample resources and guidance on requirements. Designing a correct label – one that will successfully
pass FDA’s scrutiny – often takes knowledge of accurate wording, compliant symbols, and other details.
- Manufacturer name and contact information
- Device diagram – this is not required but can be helpful in some applications
- Product identification – device identifier GTIN, part number, lot number, revision number, REF
- Unique device identifier (UDI) – most commonly in the form of a bar code or QR code
- Manufacturing and/or expiration date
- Standard symbols – Examples include single-use only, keep dry, sterilization instructions, storage
temperature, consult the instruction for use (IFU), etc.
Tips and recommendations for medical device labels
There are numerous considerations when creating a medical device label. Our first and foremost recommendation is to start working on your label (or bring in an experienced printing partner) early in the product development process. While labels may not be as complicated (or exciting) as the medical device itself, they often take longer to create than most product designers assume.
If you have similar products, developing a label template that is easy to replicate and fill in with applicable information can save you time and effort down the right. Finally, what the label is made from is just as important as what it says. Durable materials must be selected to ensure the label stays intact and legible, even when exposed to harsh environmental factors such as cleaning chemicals.
At Tapecon, we have extensive experience designing and manufacturing high-quality medical device labels in our FDA-registered facility. Let our team take the guesswork out of the label so you can focus on creating your product.
Let’s make something great
With over 100 years of manufacturing experience, Tapecon works with product teams to solve challenges, create products, and enhance lives. Learn more about our labels and decals applications.