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FDA Human Factors Regulatory Roundup (ft. Janet Creaser)
Manage episode 363807501 series 3462345
محتوای ارائه شده توسط Human Factors Cast. تمام محتوای پادکست شامل قسمت‌ها، گرافیک‌ها و توضیحات پادکست مستقیماً توسط Human Factors Cast یا شریک پلتفرم پادکست آن‌ها آپلود و ارائه می‌شوند. اگر فکر می‌کنید شخصی بدون اجازه شما از اثر دارای حق نسخه‌برداری شما استفاده می‌کند، می‌توانید روندی که در اینجا شرح داده شده است را دنبال کنید.https://fa.player.fm/legal
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In our first regulatory roundup segment ever we talk to Janet Creaser about the FDA’s newest human factors draft guidance released in December 2022, Content of Human Factors Information in Medical Device Marketing Submissions.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- FDA Draft Guidance (December, 2022): Content of Human Factors Information in Medical Device Marketing Submissions
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