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USFDA Guidance: Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products

Today (08 July, 2024) the US Food and Drug Administration (FDA) has released guidance "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products".


This guidance provides an in-depth look on the purpose and content of a use-related risk analysis (URRA) and how a URRA, along with other information, can be used to determine human factors (HF) data needs during product development and to support a marketing application.


Use-related risk analysis (URRA): A risk analysis tool used to identify use-related hazards associated with medical product use and the measures implemented to reduce associated risks.


It supports the entire HF engineering process and is part of the overall risk management framework. The URRA is crucial for identifying hazards in the user interface design of combination products, characterizing risks, and mitigating or eliminating them through improved design.

The URRA should encompass:

  • A detailed list of all tasks required for product use.

  • Identification of potential use errors and associated harms for each task.

  • Determination of whether each task is critical.

  • Risk controls implemented in the user interface design to mitigate use errors.

  • Evaluation methods used or planned to assess the effectiveness of these risk controls.

Sponsors should begin developing URRA early in the product development process, then use and update it throughout the product lifecycle, for example, as the design changes, or as new risks become apparent during development.

Sponsors should consider all the intended uses, potential users, and likely use environments when developing the URRA. In each case, the product design, user tasks, and the potential risks and harms associated with its use may be impacted. For more information on human factors and use-related risk, sponsors should refer to the FDA and industry guidance Applying Human Factors and Usability Engineering to Medical Devices.


By following the outlined components and considerations, sponsors can enhance the safety and efficacy of their products, ensuring better outcomes for users. For more detailed information, refer to the full document: Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products.

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