Safety Information in Device Labeling

by Eric F Shaver, PhD

This is the first in a multipart series on the design, presentation, and evaluation of safety information (warnings, precautions, and contraindications) in device labeling.

Companies face mounting pressure to design and develop higher quality device labeling that meets the requirements of users. These pressures originate from several sources. First, over the past decade, regulatory authorities, such as the FDA, have expanded the requirements to demonstrate that users can employ labeling in order to safely and effectively operate medical and drug-delivery devices.

Second, traditional competitors, along with new market entrants, are bringing cutting-edge techniques about designing effective device labeling from other industries to medical and drug-delivery devices.

Lastly, sophisticated users are increasingly expecting device labeling to meet or exceed what they experience with their consumer products.

Each of these developments point to the importance of companies embracing new ways of designing and developing device labeling in order to maximize their success in the pre-market approval process and against their competitors.

One important, but often overlooked, aspect of device labeling is safety information, which includes warnings, precautions, and contraindications. While most companies would readily acknowledge the importance of identifying and clearly communicating the potential hazards associated with their devices, oftentimes they are perplexed about the best methods for accomplishing it.

There is a dearth of actionable resources on how to design, present, and evaluate safety information in device labeling that stakeholders can readily access. This blog post series will address this deficit. Some of the topics that will be covered include:

  • Safety information components
  • Purpose of safety information
  • When safety information is required
  • Challenges developing safety information
  • Why safety information isn’t always effective
  • Questions to ask when developing safety information
  • Design considerations when developing safety information
  • Issues seen in device labeling safety information

I look forward to sharing tips on developing safety information that clearly communicates potential hazards associated with medical and drug-delivery devices to intended users.