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FDA Human Factors Regulatory Roundup (ft. Janet Creaser)
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In the premiere episode of Safe and Effective we bring you an exciting blend of regulatory insights and live interviews from this years HFES Healthcare Symposium in Orlando, Florida.
In our first regulatory roundup segment ever we talk to Janet Creaser about the FDA’s newest human factors draft guidance released in December 2022, Content of Human Factors Information in Medical Device Marketing Submissions. We discuss its content, goal, and use, while pointing out some of its advantages, as well as weak spots.
Additionally in this episode we share some insights from this year’s HFES International Healthcare Symposium in Orlando, Florida, from our field correspond indent interviewing some of its organizers.
- Guest: Janet Creaser
- Host: Heidi Mehrzad
- FDA Draft Guidance (December, 2022): Content of Human Factors Information in Medical Device Marketing Submissions
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