FDA Proposes New Study To Test Device Labeling Standardization

By Nick Otto

The FDA is taking steps to further study the feasibility of standardizing device labeling using new formats currently under development.

A recent Federal Register notice says that the agency is planning to compare the labeling of six different medical device labels “with a standard content and format of the same labeling that FDA researchers will develop using the existing labeling as their source of information.”

“We will conduct the studies at three different sites including two area hospitals using their devices, existing labeling, and HCPs,” according to the FDA notice. “Given a sample of six devices with two 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 FDA currently lacks any concrete regulations that standardize device labeling, and the Regulatory Affairs Professionals Society (RAPS) notes a “considerable difference from 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.”

The notice is directing device makers to submit feedback on four ideas that will help the agency, including:

• If the collected information will be necessary and practical for the FDA to properly perform its functions
• If the agency accurately estimated the burdens for industry to collect the information
• Other ways to enhance the quality, utility, and clarity of the collected data
• Any ideas to lessen the burden of data collection, including the use of automated collection techniques

The FDA announced plans for a similar survey back in 2012, asking physicians, nurses and medical technicians to evaluate the labeling of a fictitious medical device for clarity, usefulness, and how user-friendly the information was. The draft survey document focused on an imaginary infusion pump.

RAPS adds that information gained from the initial 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.”

Comments on the proposal are due Nov. 12.