This is the fourth post in a multipart series on how medical device and pharmaceutical companies can continue to make progress on Human Factors-related activities during the COVID-19 crisis.
Device labeling (e.g., user manuals, instructions for use (IFU), quick start guides, on-screen instructions, posters, on-device labels, cartons, trays, etc.) is an important component of the overall device design.
Your device labeling will often be one of the risk controls that you rely on when designing a safe and effective device. If hazards cannot be designed out in the device or system, then it is incumbent for the manufacturer to provide users with clear, easy to follow device labeling.
Unfortunately, too often we see device labeling developed at the tail-end of the design process. Ideally, these materials should be prepared early and evaluated with potential end-users to identify necessary changes early in the design process. Failing to start early can result in costly delays.
Given the current restraints of face-to-face testing with users, companies are asking what can be done to progress their labeling design and development. Some efforts that can be undertaken at this time include:
- Work with human factors experts to develop a plan for your labeling development.
- Let human factors experts design and develop the necessary labeling for your device.
- Have your draft labeling reviewed by human factors experts to ensure compliance with regulatory requirements and labeling design best practices.
- Review post-market data to identify labeling design issues with currently marketed products.
- Perform a search and analysis of FDA databases to identify known use issues with related devices.
- Conduct remote testing of the draft labeling with representative end users.
- Modify your device labeling based on post-market data review, known use issue analysis, and remote testing efforts.
This is an opportune time to get your device labeling development underway. If you already have draft labeling, use this opportunity to carry out one of the activities specified above.
If you’re questioning the readiness of your device labeling, give us a call. We can help!