FDA Updates Human Factors Guidance: What Medical Device Manufacturers Need to Know
The FDA has issued an updated guidance on Applying Human Factors and Usability Engineering (HFE/UE) to Medical Devices, providing manufacturers with a clearer framework for designing devices that can be used safely and effectively by their intended users. The updated guidance was issued on August 3, 2026, replacing the original 2016 guidance. While the document contains nonbinding recommendations, it reflects the FDA’s current thinking on human factors engineering and usabili
