Lauren Orme

Lauren Orme

Director of Regulatory Policy and Intelligence

April 11, 2024

Human Factors Considerations for Combination Products – Recent FDA Guidance

On September 7th, 2023, a long-awaited final guidance was issued by the Food and Drug Administration (FDA) - Application of Human Factors Engineering Principles for Combination Products: Questions and Answers. The document is intended to be used in conjunction with other human factors related guidance and available national and international standards, such as AAMI HE75 and IEC 62366. In this latest guidance, the agency provides its view on best practices for conducting human factors activities for combination products either comprised of a device and a drug or a device and biologic.

Recent FDA Guidance, Combination Products by Lauren Orme, Director of Regulatory Policy & Intelligence

Human Factors is the application of knowledge about human behaviors, abilities, limitations, and other characteristics of the users to the design of products to help ensure safe and effective use of the product1. For combination products, this application is applied individually to the respective device and drug/biologic constituents but also to the combination product as a whole. Therefore, it is critical for Drug/Biologic and device manufacturers to work in collaboration on holistic evaluations of use related risk, critical tasks, user interfaces, and study design of the final finished combination product.

Use Related Risk Analysis (URRA)

A comprehensive risk analysis is required for medical devices and for drug or biologic products, respectively. For use related risk, the existing individual risk analyses that exist for the drug/biologic and device should be reviewed to determine if any risks exist for the combination product as a whole that may not exist for each individual constituent. The URRA should focus on the potential hazards associated with the intended use of the final finished combination product, but also consider reasonably foreseeable misuse, users, use environment and user interface. For example, a higher viscosity drug combined with a smaller gauge needle on the device could cause more pain during injection, which could cause user’s to prematurely remove the device and lead to an underdose. This user related risk would be specific to this combination of drug/device but may not be present with a different drug and/or a different device. Therefore, evaluation should be conducted on all of the tasks involved with using the bespoke combination product, identifying the potential use errors or failures that could occur and potential clinical consequences of those errors and/or failures. The resulting output is then used to define critical tasks.

Combination products that include a device and drug/biologic need a holistic human factors evaluation, driven by risk and user considerations, to take the respective considerations of each constituent and add any additional unique considerations for the final product as a whole. Therefore, strong partnerships between the drug/biologic and device manufacturers are needed to ensure the various perspectives and expertise from each side are considered in that holistic evaluation.

Interested in learning more on the recent FDA guidance on human factors considerations for combination products? Check out our regulatory insights paper below.

Download Paper

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