FDA Issues New Guidance on Human Factors Testing for Medical Devices
16 February 2016FDA Alert
On February 3, 2016, the Food and Drug Administration (FDA or the agency) released three guidance documents on human factors and usability engineering for medical devices. Applying Human Factors and Usability Engineering to Medical Devices is a final version of a 2011 draft guidance and will also supersede one of the agency’s earliest guidance documents on human factors and risk management. The other two newly released draft guidance documents address the types of devices most likely to require pre-market human factors testing and human factors considerations particular to the development of combination products. Together, the three new guidance documents reflect a recent FDA trend of placing greater emphasis on human factors (HF) considerations and assessments in medical device pre-market submissions and, at times, in the post-market setting.