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 Upon receiving the AI letter, appoint a lead person and disseminate the letter among team members for review. Average Number of Industry Days to MDUFA IV Decision 54.69 Average Number of Total Days to MDUFA IV Decision 127.31
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