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. These AI requests often address complicated scientific scenarios in which a submitter has already provided some information, but FDA is not completely satisfied.
Let's personalize your content