U.S. Food and Drug Administration (2019)

FDA.

URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices

Abstract. The FDA's guidance for industry on applying human-factors and usability engineering to medical-device submissions. The regulatory baseline for medical-device UX practice in the US, describing summative-validation expectations, residual-risk analyses, and the user-interface specification deliverable.

Tags: healthcare regulatory fda medical-devices

Textbook of Usability

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