FDA and other global regulators expect to see appropriate processes to account for human factors and usability in a range of products to ensure that they are safe and effective at the end-user level.  

Human Factors refer to how people interact with technologies and system design. 

Usability refers to the quality of a person’s interaction with products or systems. 
During the June 2021 Redica Systems webinar, “Human Factors | Compliance and Applications,” presenters Alison Sathe and Valerie Fenster identified regulated products that must account for human factors and usability.

  • Medical devices (professional use devices, home use devices, Software-as-a-Medical-Device such as mobile and Web apps)
  • Drug products (pediatric use, complex dosing regimens)
  • Combination products (drug delivery systems, IVD companion diagnostic devices)
  • Packaging and labeling (instructions, trays, device labels, etc.)

Human factors is an area that’s often considered strictly the domain of medical devices and combination products but human factors and usability affect all kinds of medtech products.

“Combination Products” is one site tag category that can be used to filter inspection results in Redica. Contact us today to learn more about how we can help you fine-tune your inspection preparation to reflect your site’s specific requirements.

Combination Products Site Tag
Redica Systems Enforcement Analytics | Combination Products Site Tag

Getting Smart with Human Factors and Usability

So-called “smart” devices and combination products that are interconnected to other devices and the World Wide Web, are an emerging market of product that require extensive human factors and usability engineering. 

“Combination products” which consist of products that merge drugs, biologics, or medical devices into a single therapeutic solution are another growing healthcare market. Human factors and usability are crucial for combination products, particularly when it comes to the potential for medication errors. 

Ultimately, a robust human factors and usability engineering strategy helps ensure the production of quality products safe for patient use.

Additional Human Factors and Usability Resources

Webinar – Human Factors | Compliance and Applications

What is Your Human Factors Engineering Strategy?

The Current State of Smart Devices and Combination Products

Surveying the Smart Combination Product Ecosystem

FDA Combination Products Policy and Guidance Changes

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