Guideline on the FDA's Employment of Human Factors Engineering Rules for Combination Products
The Food and Drug Administration (FDA) has released its final guidance on human factors studies for combination products, providing a more rigorous, integrated, and iterative approach to human factors engineering [1]. This guidance aims to ensure the safety and effectiveness of combination products, which are made up of a device, drug, or biologic component, packaging, labeling, and user training.
The guidance mandates a system-level approach, requiring manufacturers to analyse and validate the entire combination product user interface as a unified system. Usability must be addressed at this system level, not just for individual components.
The definition of "critical tasks" has been expanded. Any task is now considered critical if, when performed incorrectly or omitted, it could result in any level of harm to the user or patient—regardless of severity. This broadens the scope of what must be assessed and validated compared to previous guidance that focused on “serious” harm.
Human factors validation must demonstrate that users can safely and effectively perform all critical tasks across the integrated system before regulatory submission or pivotal clinical studies. Findings from post-market surveillance should be integrated back into usability testing protocols and design refinement, ensuring a continuous feedback loop for product safety.
The guidance details best practices for formative and summative usability testing, usability risk management, task analysis, and interface design. It specifies how user training and labeling should be integrated into risk mitigation strategies. There are formal recommendations on how human factors evidence should be incorporated into clinical study protocols and regulatory submissions for FDA review.
The guidance encourages the use of real-world evidence from post-market surveillance to further refine product safety and effectiveness, supporting iterative design improvements. The emphasis is on demonstrating the holistic safety and effectiveness of the entire product configuration under actual use conditions, moving beyond isolated component testing.
The FDA's human factors guidance can be applied to medical devices and combination products. The characteristics of drug and device constituent parts, user populations, and potential for medication errors inform the design of the user interface. The guidance reflects a more rigorous, integrated, and iterative approach to human factors engineering for combination products, with a clear focus on patient safety across all aspects of the product lifecycle.
Notably, Sterling Medical Devices, with decades of experience using human factors engineering to improve the design of medical devices, has embraced this new guidance. The company is poised to leverage its expertise to help manufacturers navigate the complexities of human factors validation for combination products, ultimately enhancing patient safety.
[1] Food and Drug Administration. (2023). Human Factors Studies for Combination Products. Retrieved from https://www.fda.gov/medical-devices/guidance-documents/human-factors-studies-combination-products
- The new FDA guidance for human factors studies applies to medical devices and combination products, considering the characteristics of drug and device constituent parts, user populations, and potential for medication errors when designing the user interface.
- The human factors validation process requires manufacturers to demonstrate that users can perform all critical tasks safely and effectively across the entire product's integrated system before regulatory submission or pivotal clinical studies.
- The guidance encourages the use of real-world evidence from post-market surveillance to refine product safety and effectiveness, supporting iterative design improvements and moving beyond isolated component testing.
- Recognizing the complexities of human factors validation for combination products, Sterling Medical Devices, with decades of experience in human factors engineering for medical devices, is ready to assist manufacturers in navigating these challenges, ultimately prioritizing patient safety.
