Regulatory Focus™ > News Articles > FDA to Test out New Standardized Medical Device Labels in Proposed Study

FDA to Test out New Standardized Medical Device Labels in Proposed Study

Posted 15 September 2014 | By Alexander Gaffney, RAC

FDA to Test out New Standardized Medical Device Labels in Proposed Study

The US Food and Drug Administration (FDA) plans to study whether it could standardize device labeling with the use of new content and format standards now under development.


At present, there are no regulations defining a standardized approach for how content should be structured or formatted for medical devices. This is considerably different than the requirements for other FDA-regulated products, such as food or pharmaceutical products, which must adhere to strict requirements regarding everything from the font size and required information to layout and required statements.

But among FDA officials, there is a growing recognition that a lack of standardization is potentially harming patients. There is 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," FDA wrote in a 4 January 2013 Federal Register announcement regarding device labeling.

In addition, "There is no single available source of medical device labeling for people to view, search and download for devices that are used in clinical and non-clinical environments," FDA wrote. Unlike pharmaceutical products, which typically have a shorter shelf life, the longevity of medical devices may mean that their instructions for use and warning labels are damaged or illegible after a few years. If these labels are unavailable, patients may be harmed as a result.

But patients could also come to harm even if the labels are present, FDA said. "FDA is concerned that the lack of standard content and format may translate into an increased risk of medical device error," it wrote. If a warning section, for example, is placed in an unusual section, a physician may inadvertently skip over it, potentially subjecting a patient to unnecessary harms.

With these facts in mind, FDA said it has already conducted a two-phase research study with Research Triangle Institute to poll "healthcare professionals" on what information they would want in a standardized device label. The information obtained from that research has since been turned into an outline for a standard format, but FDA noted participants in both that study and a subsequent one expressed a desire to see a kind of "quick guide" to describe the device's most critical information in an at-a-glance format.

New Device Labeling Initiative

Now the agency says it wants to move forward with an additional study on standardized device labeling.

In a 12 September 2014 Federal Register posting, FDA says it plans to compare labeling from six different types of medical devices using two different "standard content and format" labels being developed by FDA researchers.

As with the agency's first study, the new study is to be quite small, with just 38 respondents—all healthcare providers. Of the 38, eight will be hospital-based healthcare providers, while the remaining 30 will be healthcare providers "participating at FDA."

"We will conduct the studies at three different sites including two area hospitals using their devices, existing labeling, and HCPs," FDA explained in the notice. "Given a sample of 6 devices with 2 different labeling types, there will be 12 different labeling types to be tested. We plan to have eight people test each type of the labeling. We will also conduct the studies on FDA's campus using medical devices received from medical device industry representatives through a material transfer agreement."

The study is yet another indication that FDA is seriously considering how to standardize device labels, and its second study could mean new standards could be arriving within a few years.

To be seen: Whether devices will adhere to a single format or several depending on their intended use and use settings (e.g. hospital vs. home use settings). For now, FDA seems to be indicating that it has not yet decided on a single labeling format, but the two being studied might soon be narrowed down to a single format.


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