Regulatory & Reimbursement
FDA Output, September 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in September 2026. Updated September 14.
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Regulatory & Reimbursement
FDA Output, September 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in September 2026. Updated September 14.
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Regulatory & Reimbursement
FDA Taps Tech Chief, Key Staffer Departs, EU Procurement Reform, and More
In this week’s Pathways Picks: Medtech and digital health veteran Jared Seehafer is FDA’s first Deputy Commissioner for Technology and Artificial Intelligence; digital health leader Anindita Saha leaves the agency; Europe proposes to simplify its procurement rules; South Korea surveillance exemptions; and more medtech policy updates.