Human Factors Engineering in Medical Products Reviews (2of14) REdI 2018

CDRH’s Kimberly Kontson and CDER’s Quynh Nhu Nguyen provide an overview of human factors in medical products, human factors research at FDA, combination product considerations, and usability engineering at CDRH.
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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

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