Medical Device Labeling and Regulation

Medical devices require a lot of proper care to produce and market. When people use such devices, they’re doing it for the purpose of staying healthy or treating a specific ailment. Incorrect labeling can create confusion, lead to health risks, or make it impossible to properly use the product. As a result, the label on the package must be as informative and accurate as possible. This isn’t just due to ethics but necessity and government regulation.

There’s no mystery to solve when it comes to which agency regulates the manufacturing and labeling of medical devices, and the regulations themselves are easy to find. The FDA is responsible for setting the standards a company must follow when labeling a medical device.

What Counts as Medical Labeling?

Medical device labeling regulations apply to all medical products, from pharmaceuticals to hospital tools and everything in between. To know if your product qualifies as a medical product and is thus covered under the FDA’s guidelines, consider using the FDA’s definition to help you.

The FDA defines a medical device, or medical product, as something designed to diagnose, cure, prevent, or treat someone suffering from a medical condition or anything that changes how the body functions or is structured. If your product provides any sort of health information, healthcare, or medical aid, it’s a medical device that must be labeled properly.

A label is any written, printed, or graphic matter on a product container. Advertising materials have also been ruled to qualify as labels that must be regulated; this includes posters, instructional booklets, pamphlets, and similar.

Thus, any label that goes onto or is distributed alongside a medical device is a medical label, subject to FDA regulations. It’s vitally important to get such labels right before distribution. This job usually goes to the product manufacturer; however, other groups working in the supply chain may instead have to handle the job. As a result, everybody who works on a medical device must be aware of the medical device regulation labeling requirements in case they are responsible for producing the labels.

FDA Regulations for Medical Device Labeling

When it comes to FDA labeling regulations, medical devices have specific criteria that must be followed to ensure the safety of the patient when the product is being used. There are also general FDA regulations that all labels must fit, such as being entirely accurate to the product and not containing any false or misleading information. While also important for products such as food, medical devices require this amount of scrutiny to keep people safe when using them.

All medical device labels must include:

• The manufacturer’s name, as well as the address of the company.
• Proper instructions on how to use the device.
• The intended use of the device.
• A “Unique Device Label,” or UDI, so that the device can be identified properly to everyone and stored in the Global Unique Device Identification Database.

Many other medical device labels must include more information. For example, a product such as a hearing aid will need to come with accompanying material, such as information on how the device works and patient release forms. These all qualify as labels and must be held to FDA regulations.

The appearance of a label is also subject to regulation. This includes remaining legible and thus being a label that anyone can read if necessary. The label is also expected to remain on the container for as long as the device is meant to exist. In this way, at any time someone needs to use or distribute the device, the label is not damaged, hard to read, or otherwise ruined before or during the process. Proper use of standardized symbols is also a must to ensure the product is used and stored appropriately.

Hire Royal Label for Medical Device Labeling

There’s a lot that goes into properly labeling a medical device. In addition to following the FDA guidelines and producing a quality, reliable label, there are other things that a manufacturer must consider.

Royal Label is the custom label company you can trust to follow FDA regulations, create sturdy and reliable labels that can be produced in large quantities, and ensure your devices will remain properly labeled in the future. Contact us today to learn more about our custom labeling services.