Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach
FDA Law Blog
JULY 10, 2023
Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. By Day 100 If MDUFA Decision is not reached by Day 100, FDA provides Missed MDUFA Decision Communication that identifies outstanding review issues. 510(k) Time to MDUFA IV Decision.
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