Presentation
MDD20 - It’s a Risky Business: Navigating Recent FDA Requirements For Your Product’s Use-Related Risk Analysis (URRA) As Part Of Your Regulatory Submission
DescriptionAs most Human Factors Engineering (HFE) professionals within the medical field are probably aware, the U.S. Food & Drug Administration (FDA) expects manufacturers to demonstrate that their product can be used safely and effectively. One of the key cornerstones of doing so is to develop a use-related risk analysis (URRA), which evaluates potential use-related hazards, including lessons learned from reported errors with similar products. This assessment informs the device design development of mitigations to eliminate or minimize use errors that could cause (serious) harm or compromise medical treatment.
URRAs, in the context of medical devices, typically align with the principles outlined in ISO 14971. This is an international standard that provides a structured approach for managing risks associated with medical devices throughout their lifecycle. ISO 14971 guides manufacturers in identifying, assessing, and mitigating risks that may arise from the intended use and reasonably foreseeable misuse of a medical device. Manufacturers are encouraged to consider factors such as user interface, intended use scenarios, potential errors, and misuse during this process.
Although ISO 14971 provides helpful tools to conduct comprehensive risk analyses, it does not directly explain how to incorporate a URRA into your HFE process. Nor does it describe how your risks might impact your regulatory submission. In fact, since ISO 14971’s latest release in 2019, the FDA has issued several other guidance documents that describe their expectations for URRAs and their role within the medical device development process.
For example, in December 2022, the FDA issued a new draft HFE guidance document, Content of Human Factors Information in Medical Device Marketing Submissions. This new guidance is intended to complement the FDA’s final HFE guidance from 2016, Applying Human Factors and Usability Engineering to Medical Devices. The new guidance outlines what evaluation information to include in a marketing submission, and places an important focus on the URRA. Specifically, the guidance enables manufacturers to evaluate modifications to an existing device through a risk-oriented lens and determine to what extent HFE work needs to be conducted. The presenter has contributed to risk analyses and user interface comparisons where the primary goal was to justify from a use-related risk perspective that the device did not warrant HF validation testing. These have resulted in successful submissions to the FDA. This presentation will include learnings and how-to tips resulting from this process.
In addition, in September 2023, the FDA also released a Q&A guidance document, Application of Human Factors Engineering Principles for Combination Products: Questions and Answers. This guidance expands upon nuanced considerations when applying HFE during the development of combination products, and per the document’s introduction, finalizes the February 2016 draft version titled Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development. This guidance document states that a URRA should be conducted prior to clinical investigations. This URRA effort aims to protect clinical investigation subjects and ensure that clinical investigation’s results are not jeopardized. The presenter intends to continue the dialogue about use-related risk analyses within a wider context, and offer considerations using a step-by-step approach to navigate use-related risks throughout the product development journey.
In conclusion, in this presentation, the presenter will describe the regulatory expectations for conducting URRAs as part of the medical device development process. Specifically, the presenter will briefly describe the recently released FDA guidance documents and latest expectations, discuss considerations and challenges for implementing a solid URRA strategy into your product development process, and recommend some strategies to overcome those challenges. In addition, the presenter will explore how URRA data can be leveraged to efficiently navigate manufacturers’ HF submission for both medical devices and combination products.
URRAs, in the context of medical devices, typically align with the principles outlined in ISO 14971. This is an international standard that provides a structured approach for managing risks associated with medical devices throughout their lifecycle. ISO 14971 guides manufacturers in identifying, assessing, and mitigating risks that may arise from the intended use and reasonably foreseeable misuse of a medical device. Manufacturers are encouraged to consider factors such as user interface, intended use scenarios, potential errors, and misuse during this process.
Although ISO 14971 provides helpful tools to conduct comprehensive risk analyses, it does not directly explain how to incorporate a URRA into your HFE process. Nor does it describe how your risks might impact your regulatory submission. In fact, since ISO 14971’s latest release in 2019, the FDA has issued several other guidance documents that describe their expectations for URRAs and their role within the medical device development process.
For example, in December 2022, the FDA issued a new draft HFE guidance document, Content of Human Factors Information in Medical Device Marketing Submissions. This new guidance is intended to complement the FDA’s final HFE guidance from 2016, Applying Human Factors and Usability Engineering to Medical Devices. The new guidance outlines what evaluation information to include in a marketing submission, and places an important focus on the URRA. Specifically, the guidance enables manufacturers to evaluate modifications to an existing device through a risk-oriented lens and determine to what extent HFE work needs to be conducted. The presenter has contributed to risk analyses and user interface comparisons where the primary goal was to justify from a use-related risk perspective that the device did not warrant HF validation testing. These have resulted in successful submissions to the FDA. This presentation will include learnings and how-to tips resulting from this process.
In addition, in September 2023, the FDA also released a Q&A guidance document, Application of Human Factors Engineering Principles for Combination Products: Questions and Answers. This guidance expands upon nuanced considerations when applying HFE during the development of combination products, and per the document’s introduction, finalizes the February 2016 draft version titled Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development. This guidance document states that a URRA should be conducted prior to clinical investigations. This URRA effort aims to protect clinical investigation subjects and ensure that clinical investigation’s results are not jeopardized. The presenter intends to continue the dialogue about use-related risk analyses within a wider context, and offer considerations using a step-by-step approach to navigate use-related risks throughout the product development journey.
In conclusion, in this presentation, the presenter will describe the regulatory expectations for conducting URRAs as part of the medical device development process. Specifically, the presenter will briefly describe the recently released FDA guidance documents and latest expectations, discuss considerations and challenges for implementing a solid URRA strategy into your product development process, and recommend some strategies to overcome those challenges. In addition, the presenter will explore how URRA data can be leveraged to efficiently navigate manufacturers’ HF submission for both medical devices and combination products.
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