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

FDA Law Blog

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 Upon receiving the AI letter, appoint a lead person and disseminate the letter among team members for review. Average Number of Industry Days to MDUFA IV Decision 54.69 Average Number of Total Days to MDUFA IV Decision 127.31

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Reducing cancer deaths, one test at a time

Permanente Medicine

By building an integrated, patient-centered colorectal cancer screening program, we doubled screening rates, cut deaths by 50%, and made major strides in closing racial disparities in outcomes. The approach was simple: consistently alert patients that it’s time to get screened and make getting screened as easy as possible.

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The Promise and Pitfalls of AI in Medicine: Guest Bob Wachter

GeriPal

Alex: In 2019 … You wrote two viewpoints about AI recently in JAMA, relatively recently. I guess, 2019, and then, one again about last month or so. That’s a risk with electronic health records in general. I think, the long haul, it’s really hard to know where this goes. Eric: Yeah. Eric: Yeah.