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

FDA Law Blog

When a firm submits a Traditional 510(k), FDA first performs the acceptance review to determine whether a submission is administratively complete, or passes the technical screening for an electronic submission submitted using the eSTAR. An AI letter typically begins with the most significant deficiencies.

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Artificial Intelligence: Charlotta Lindvall, Matt DeCamp, Sei Lee

GeriPal

Audio: [electronic voice] Alex Smith has been taken over by an artificial intelligence. Five minute appointments. Charlotta: But that’s where generative AI, what I’m like, one thing I’m really excited about is this new field called prompt engineering. This is Eric Widera.

IT 99
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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. Or have electronic health record prompts so people remember to ask it?

IT 102