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Former FDA Reviewer Explains ‘Factoring’ For Human Factors At RAPS

 
• By Elizabeth Orr

At RAPS Convergence in Montreal, former FDA reviewer Rita Lin discussed the ways the agency wants to see developers consider human factors.

Profiles of a group of men and women of diverse cultures.
• Source: Shutterstock

Trying to ensure a smooth path through the US Food and Drug Administration for your device or combination product? Don’t forget to factor in human factors, Rita Lin, director of human factors engineering at consulting firm Agilis by Kymanox, said on 4 October at RAPS Convergence in Montreal.

Lin, who was a human factors reviewer at the FDA’s device center from 2017 until 2022, said that the question FDA reviewers are trained to consider was, “Looking at the...

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