Medical device labeling in the news: FDA study

Medical device labeling in the news: FDA study

The U.S. Food and Drug Administration (FDA) provides precise guidelines for pharmaceutical labeling, from what information must be included to how it is laid out – even the font size required. So, these labels are largely standardized. Contrast that with labels for medical devices, which are somewhat regulated under 21 CFR 801 – but in less detail than pharmaceuticals. The FDA therefore decided to study the medical device industry to determine how labeling can become more standardized – and how that might benefit healthcare providers to understand and explain risks and benefits of a particular device to potential users. To quote the FDA, there exists a “growing need for medical device labeling to be delivered in a clear, concise and readily accessible format so that patients, caregivers and healthcare providers may access and utilize device labeling as efficiently and effectively as possible.”

Another medical device label issue

Because labeling formats differ, it is more difficult for patients to compare and contrast information between products. Plus, because people tend to use medical devices for a longer period of time than one month (a typical usage period for a bottle of prescribed medicine), warning and usage labels can fade or otherwise become hard to read. Because of these challenges, the FDA began a pilot study in September 2014. Using two hospitals and several dozen health care professionals as a test, they started studying 12 device labeling standards to determine what is most effective. One potential solution, first officially discussed in April 2013, involved the creation of standardized symbols to be used in medical device labels. Another idea involves an online database of devices used in home healthcare. The study is being overseen by the FDA’s Entrepreneurs-in-Residence.

What do new standards for medical device labels mean for you?

As a medical device professional, you’re probably feeling some concern over potentially rigid standards – and that’s only natural. As early as May 2013, device spokespersons have requested some flexibility from the FDA as they create standards – in part because there is such a broad range of medical devices that one set of standards can’t work for all types. Industry experts also point out that laboratory-use-only devices are quite different from home healthcare ones, and should be exempt from this standardization. Manufacturer Johnson & Johnson also brought up a practical concern. If standards require packaging near a sterile device, this could affect sterilization as well as shipping requirements. This issue is unlikely to be fully resolved any time soon, but you can count on Adhesa Plate to fulfill your medical device label needs, both now and in the future as standards evolve. If you have questions or want to talk about your labeling needs, call 1-800-634-9701 now or email us at

Adhesive Labels for the Medical Industry

Proper equipment labeling is an important part of a health facility’s risk management plan. Each piece of equipment, from IV pump to a hospital bed, requires some form of labeling. The message the label carries is dependent on the function of the device.

While hospitals, doctor’s offices, and other healthcare facilities are under constant pressure to meet governmental standards, most labeling falls to the equipment manufacturer.

Medical equipment manufacturers must make sure their devices meet the stringent standards of their industry. Before a piece of medical equipment is approved for sale, it undergoes testing and regulation reviews. Part of that approval process includes making sure the device is properly labeled with UL 969 approved medical device labels.

Medical Device Classes

The required labeling for a medical device is determined by its class:

Class I – Class I devices pose a negligible safety risk to patients and service providers. Stethoscopes and forceps are Class I devices.

Class II – These devices are subject to FD&CA, standards, as specified in Section 514. Endoscopes and surgical lasers are Class II devices.

Class III – These are typically life-support apparatuses, which must be approved for sale to patients and medical facilities. A cardiac pacemaker is a Class III device.

The use of UL-approved labels and especially UL 969 certified labels will ensure the label stays in place and stands up against heavy usage or possible malfunction.

Why is UL Certification Important in Medical Labeling?

UL is an independent safety certification company. UL trains, tests, and certifies individuals and groups in the labeling industry.

UL has been offering these services for more than four decades. UL tests labels for the medical industry under the UL 969 PDGQ2 certification to ensure that they meet performance standards, adhere to regulations, and satisfy the customers’ needs. UL 969 approved labels will not curl, shrink, or fade due to conditions such as exposure to sunlight, changes in temperature, high humidity or contact with solvents or cleaning solutions.

Types of Medical Device Labels

The actual label type depends on the function of the device. For example, x-ray machines require a warning label specifying the necessary safety practices that need to be observed. Another example, medical membrane switches can be customized to particular devices, such as equipment monitors and IV pumps. Membrane switches offer a “NEMA 4 seal” that keeps moisture from penetrating into the device.

Other common labels in the medical device manufacturing industry:

  • Back Panel Labels
  • Graphic Overlays
  • FCC labels
  • ID Labels

Contact Us

At Adhesa Plate, you can rest assured that our UL recognized and UL 969 certified labels will meet your needs and stand the test of constant use. We are experts in helping our clients determine the best labels and customized solutions. Adhesa Plate will help your company succeed in the medical equipment marketplace, where 1st impressions are so critical.