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

FDA Law Blog

After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.

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Coping with Serious Illness: Danielle Chammas and Amanda Moment

GeriPal

Somebody shouts at my front Desk staff because they’re pissed off about their appointment time. I said, you know, I don’t usually start my appointments in laughter. And I think that’s why by the end of the appointment, we were able to go to equally deep places that were pretty dark and pretty heavy together.

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Artificial Intelligence: Charlotta Lindvall, Matt DeCamp, Sei Lee

GeriPal

Charlotta: Yeah, I think it will be in reducing the need to spend so many hours on documentation and looking through the EHR for information. Five minute appointments. And what we are seeing in our research is that, we’re working on GPT four, is volunteering information that we didn’t ask for. Eric: Please respond.

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Time to stop driving? Podcast with Emmy Betz and Terri Cassidy

GeriPal

We learned this and much more, and I had a great time making engine noises singing the Woody Guthrie song “driving in my car.” . If they’re in a major car crash, they’re going to have more long-term complications probably than a 20-year-old would. I can get you guys that information. OT programs).

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