Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach
FDA Law Blog
JULY 10, 2023
FDA Day (in calendar days) FDA Actions Day 1 FDA receives 510(k) submission. A best-case scenario for a firm would be that FDA does not place the submission on hold and clears it within 90 total calendar days (or less) to reach the SE decision. Note that days are in calendar days. Note that the FDA clock uses calendar days.
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