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 Team meetings with subject matter experts can be scheduled to discuss response strategies for deficiencies that require extensive clinical, scientific, or engineering input. 510(k) Time to MDUFA IV Decision.
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