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Human Factors Review: FDA Outlines Highest Priority Devices By Zachary Brennan - Published 02 February 2016

The US Food and Drug Administration (FDA) on Tuesday released new draft guidance to inform medical device manufacturers which device types should have human factors data included in premarket submissions, as well final guidance from 2011 on applying human factors and usability engineering to medical devices.

Categories: News, US, FDA, Clinical, Due Diligence, Medical Devices, Postmarket surveillance, Product withdrawl and retirement, Quality, Research and development

Tags: FDA guidance, human factors data, medical device user interface