Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach
FDA Law Blog
JULY 10, 2023
Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 if additional testing is required or justification would suffice), responsible individuals, proposed timelines, and any clarifying questions for FDA. Average Number of Industry Days to MDUFA IV Decision 54.69
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