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Brian Feldhaus
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May 4, 2026
Insights on Evidence and Communication with FDA in Device Submissions
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10:53Brian FeldhausGUEST
Y-the question was asked, you know, over the last year, what has changed at the agency.
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10:58Brian FeldhausGUEST
I think it's probably best to look even a year before that, back to 2024, 'cause that's really when the winds of change at the agency started to blow.
B
11:07Brian FeldhausGUEST
You know, it started with Dr. Maisel's retirement in March of '24, followed quickly by Dr. Shuren's retirement.
9 MINS LATER
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20:43Chris LyleGUEST
But, you know, pick the elements that you're going to talk about and be as scientific as you can about trying to persuade the FDA team to that position.