Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff

Issue Date: August 3, 2026
Issued by: Center for Devices and Radiological Health
Topic(s): Postmarket, Premarket, 510(k), Premarket Approval (PMA)
Status: Final

Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff

This guidance document provides the FDA’s recommendations to assist industry in following appropriate human factors and usability engineering processes to maximize the likelihood that new medical devices will be safe and effective for the intended users, uses and use environments. The recommendations in this guidance document are intended to support manufacturers in improving the design of devices to minimize potential use errors and resulting harm. The FDA believes that these recommendations will enable manufacturers to assess and reduce risks associated with medical device use.

Download the Guidance Document