Presentation
MDD12 - Demystifying the CDER Guidance: URRA Framework for Combination Product Development
DescriptionThe Use-related risk analysis (URRA) was first introduced to the industry in 2016 when the FDA released the draft guidance "Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development". At the time, the FDA and consensus standards had already guided sponsors to consider use-related hazards associated with a combination product during product development. However, FDA’s 2016 draft guidance and subsequent guidance documents established what can now be used as a framework for considering use-related risk during combination product development.
While use related risk has been considered in medical product development for many years, what appears to have changed the most after 2016 was FDA’s emphasis on the URRA during the application of the human factors engineering process as well as for FDA HF regulatory submissions.
The framework provided by the FDA and consensus standards can be applied in many ways, and this has led to debate and misalignment between different functional groups across the industry as well as within organizations. However, there are methods we can apply to connect this framework to the overarching design control and risk management requirements in ways that result in better user interface design, documentation, and successful FDA submissions.
This poster presentation will address two industry wide challenges that combination product development teams often encounter:
1) How to apply the Use-related risk analysis (URRA) framework to combination product development to meet both FDA submission and design control requirements.
2) How to develop URRAs as a cross-functional team working within an overarching risk management process.
We will share our collective knowledge and successful framework and strategies, including the unique insights of former CDRH and CDER HF reviewers from the Human Factors Pre-Market Evaluation Team (HFPMET) as well as the Division of Medication Error Prevention and Analysis (DMEPA). We will present proven strategies and successful examples with right-first-time FDA submissions for safe and effective combination products. Our strategies will cover URRA techniques for early device design through post-market surveillance and everything in between.
In summary, our poster presentation will showcase unique perspectives and expertise in URRA development and FDA submissions to share best practices, reinforced by relevant examples for cross functional HFES Symposium on Human Factors and Ergonomics in Healthcare attendees.
While use related risk has been considered in medical product development for many years, what appears to have changed the most after 2016 was FDA’s emphasis on the URRA during the application of the human factors engineering process as well as for FDA HF regulatory submissions.
The framework provided by the FDA and consensus standards can be applied in many ways, and this has led to debate and misalignment between different functional groups across the industry as well as within organizations. However, there are methods we can apply to connect this framework to the overarching design control and risk management requirements in ways that result in better user interface design, documentation, and successful FDA submissions.
This poster presentation will address two industry wide challenges that combination product development teams often encounter:
1) How to apply the Use-related risk analysis (URRA) framework to combination product development to meet both FDA submission and design control requirements.
2) How to develop URRAs as a cross-functional team working within an overarching risk management process.
We will share our collective knowledge and successful framework and strategies, including the unique insights of former CDRH and CDER HF reviewers from the Human Factors Pre-Market Evaluation Team (HFPMET) as well as the Division of Medication Error Prevention and Analysis (DMEPA). We will present proven strategies and successful examples with right-first-time FDA submissions for safe and effective combination products. Our strategies will cover URRA techniques for early device design through post-market surveillance and everything in between.
In summary, our poster presentation will showcase unique perspectives and expertise in URRA development and FDA submissions to share best practices, reinforced by relevant examples for cross functional HFES Symposium on Human Factors and Ergonomics in Healthcare attendees.
Event Type
Poster Presentation
TimeTuesday, March 264:45pm - 6:15pm CDT
LocationSalon C
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives