Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach
FDA Law Blog
JULY 10, 2023
In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. However, the strategy of addressing the AI request presented in the next section of this blog post applies to all three types of 510(k)s. FDA Day (in calendar days) FDA Actions Day 1 FDA receives 510(k) submission.
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