As FDA works to ensure medical device safety and effectiveness, the agency is urging manufacturers to utilize human factors engineering during product design. After all, FDA’s Quality System Regulation on Design Controls “implies” the need for human factors, pointed out Molly Follette Story of FDA’s CDRH/ODE in a June 2012 Webinar with RAPS. And the agency remains focused on incorporating hundreds of comments on its 2011 draft guidance on “Applying Human Factors and Usability Engineering to Optimize Medical Device Design,” Ron Kaye, FDA’s Human Factors Premarket Review Team Leader, reported earlier this year at the “International Symposium on Human Factors and Ergonomics in Health Care.”
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