September 28, 2023
Final guidance draws on human factors engineering to clarify critical tasks and conduct user-related risk analysis in combination product development
On Sept. 7, the Food and Drug Administration issued final guidance for medical device manufacturers on the use of human factors engineering (HFE) studies and principles to develop combination products. Combination products are therapeutic or diagnostic products that combine two or more regulated drugs, devices, or biological products.
Written in a Q&A format, "Application of Human Factors Engineering Principles for Combination Products: Questions and Answers" replaces the agency's draft guidance from 2016, titled "Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development."
FDA states that the final guidance document should be used "in conjunction with" other existing guidance documents titled "Applying Human Factors and Usability Engineering to Medical Devices" and "Safety Considerations for Product Design to Minimize Medication Errors" to better understand the unique aspects of combination products that should be considered in the HFE process.
Human factors engineering assessments and combination products
Since a combination product comprises two or more FDA regulated components (i.e., medical device, drug, or biologic), an HFE assessment or clinical study that integrates usability assessments should consider all the components and their interactions for evaluation as part of a premarket submission.
The guidance document states that "in the context of a drug-device combination product, as part of the HFE process, design controls should include a use-related risk analysis (URRA) of the combination product as a whole," not just the individual device, drug, or biologic constituent parts (Figure 1).
HFE is the application of knowledge about human behavior and other characteristics, capabilities, or limitations of the intended user to product design to "ensure the safe and effective use of that product."
In the HFE process, it is important to consider not just the intended users themselves but also the intended uses of products, the intended use environments, and the user interface. The questions and answers presented in this final FDA guidance document provide clarification about topics including:
- How to apply HFE principles to minimize medication errors
- How a drug's properties may affect a user's capabilities or limitations in interacting with a combination product
- How identifying combination product critical tasks differs from identifying critical tasks for stand-alone devices
- How a URRA can help identify critical tasks specific to combination products, and how a URRA is related to, but distinct from, a full engineering risk analysis
- How FDA evaluates human factors validation studies
- How to consider whether, and how, training should be included in human factors validation
The publication of this final guidance document provides medical device and combination product manufacturers one more tool to use when preparing premarket submissions. Guidance documents are an excellent resource for understanding what FDA reviewers expect to see in a submission and how they would like it communicated. Attending to FDA guidance documents can help sponsors avoid deficiency responses related to content that is missing or has been ineffectively communicated to FDA reviewers.
It is important for manufacturers to recognize that the final guidance document incorporates feedback provided during the comment period for the 2016 draft guidance document and may contain different or additional information for manufacturers.
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