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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law Blog

Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 Average Number of Industry Days to MDUFA IV Decision 54.69

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Keynote: Finding your bliss—beating physician “burnout”

Pamela Wible MD

Drawing from her experience running a physician suicide helpline , she speaks candidly about the emotional toll of assembly-line medicine , the link between overwork and doctor suicide , and the revolutionary joy of reclaiming your career by launching your own ideal clinic. I was in a big-box clinic. Does that make any sense at all?

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