FDA Output
FDA Output, October 2025
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in October 2025. Updated October 15.
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FDA Output
FDA Output, October 2025
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in October 2025. Updated October 15.
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Pathways' Document Depot
Docs of the Month: France Details Digital Device Reimbursement Evidence Principles
There is not yet a clear global consensus on what constitutes sufficient evidence to support a financially sustainable launch and long-term market access of new digital devices. France’s health technology assessment body rolled out some of its answers to this question in two detailed guidelines published last month.