FDA Output
FDA Output, December 2025
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in December 2025. Updated December 15.
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Pathways' Picks
EU Reform Proposal Imminent, CMS-FDA Tag Team, and Global Updates
In this week’s Pathways Picks: MDR and IVD reform proposals expected December 16; EU-wide health technology assessments planned; paired programs from CMS and FDA to accelerate digital health; AI billing code chatter; TAP feedback; IVD handbook in India; and more policy updates from Asia, Europe, and the US.
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Market Scorecard
Market Pathways Scorecard: PCCPs at FDA, 2025 Edition
A infographic look at FDA's use of Predetermined Change Control Plans.