An Overview of the FDA’s Application of Human Factors Engineering Principles for Combination Products Guidance

Medical professional pointing at FDA icon.
Medical professional pointing at FDA icon.

In September 2023, the FDA Office of Combination Products (OCP) released the Application of Human Factors Engineering Principles for Combination Products, a finalized version of the February 2016 draft document. The updated document offers guidance on applying human factors engineering (HFE) principles throughout the combination product’s design and development lifecycle. Developed in an easy-to-read Q&A format, the document clarifies how the unique aspects of combination products influence the considerations within the HFE process.

What’s included in the FDA human factors combination product guidance?

The FDA’s finalized combination product guidance covers HFE principles for combination products that are submitted to the FDA Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), or the Center for Devices and Radiological Health (CDRH). It answers some of the most common questions related to the various complexities associated with HFE for combination products.

Specifically, the FDA human factors combination product guidance addresses topics related to HFE considerations for combination products, including:

  • How the characteristics of drug and device constituent parts, user populations, and potential for medication errors inform the design of the user interface and impact HFE considerations
  • The definition of a combination product critical task
  • Additional factors to be considered due to drug and device constituent parts being used together
  • Training as part of the user interface
  • Human factors validation data that may be included in a premarket submission
  • Details related to human factors validation studies and formative evaluations
  • Which human factors engineering principles should be considered when modifying a combination product
  • And more…

Because combination products are comprised of two or more different types of products, such as a device with a biologic or a device-drug combination, the FDA guidance is based on statutory and regulatory requirements applicable to drugs, devices, and biological products. Even when combined, each component maintains its own specific regulatory standards.

The FDA recommends using the human factors guidance in conjunction with other critical guidance, including Applying Human Factors and Usability Engineering to Medical Devices and Safety Considerations for Product Design to Minimize Medication Errors, as well as existing guidance developed by the CBER, the CDER, the Center for Devices and Radiological Health (CDRH), and the OCP that describe other aspects of product development.Sterling Medical Devices has decades of experience using human factors engineering to improve the design of medical devices. For more information about how to apply the FDA’s human factors guidance to your combination product or medical device, or to discuss other issues related to the FDA’s regulations for software development, contact us here.

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