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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law Blog

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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10 Things To Do To Keep Your Heart Happy

Georgetown Pediatrics & Family Medicine

According to the CDC, “About 697,000 people in the United States died from heart disease in 2020– that’s 1 in every 5 deaths”. Cholesterol, sugars, kidney, liver and electrolytes are typically screened during annual wellness visits. It is important to always schedule the next follow up appointment to prevent refill delays.