Draft Guidance on Use-Related Risk Analysis for Combination Products

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In a significant move aimed at enhancing the safety and effectiveness of combination products, the U.S. Food and Drug Administration (FDA) has recently released a draft guidance document focusing on the use-related risk analysis (URRA) for these complex products. This draft guidance represents a crucial step in refining regulatory practices and ensuring that combination products—those that combine drugs, devices, and/or biologics—meet high safety and efficacy standards.

Overview of the Draft Guidance

The draft guidance released by the FDA is titled “Purpose and Content of Use Related Risk Analyses for Drugs, Biological Products, and Combination Products”. URRAs are instrumental in how use-related hazards can be identified and mitigated through design risk analysis, and are an integral part of the process for an investigational new drug application (IND), a new drug application (NDA), or a biologics license application (BLA).  While human factors (HF) are not within the scope of this guidance, it is urged that manufacturers take into account how URRAs can incorporate HF at products’ early-stage development and throughout their lifecycle.

Key aspects of the draft guidance include:

  • Definition of Use-Related Risks: The FDA defines use-related risks as those that stem from how a product is used by patients, caregivers, or healthcare professionals. These risks are distinct from inherent risks associated with the product’s components and their intended effects.
  • Analytical Framework for Risk Assessment: The guidance outlines a framework for conducting use-related risk analyses. It emphasizes the need for a systematic approach that includes identifying potential use-related hazards, assessing their severity and likelihood, and implementing strategies to mitigate identified risks.
  • Importance of Human Factors Engineering (HFE): The draft document highlights the role of Human Factors Engineering in the development of combination products. HFE principles are essential for designing products that are intuitive and user-friendly, thereby reducing the risk of use errors.
  • Methods for Risk Evaluation: The guidance describes various methods for evaluating use-related risks, including formative and summative human factors studies. It encourages manufacturers to engage in iterative testing and refinement processes to address potential issues before the product reaches the market.
  • Documentation and Submission Requirements: The draft guidance provides recommendations on how to document the results of the use-related risk analysis and integrate this information into regulatory submissions. Clear and thorough documentation is crucial for demonstrating that risks have been identified and addressed.

The FDA is seeking feedback from stakeholders until September 9, 2024. Read the guidance here.

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