FDA Output
FDA Output, March 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in March 2026. Updated March 5.
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PECA Labs: Enhanced Cardiovascular Implants for Children and Adults
A Pittsburgh-based start-up originating from a personal cause is making safer vascular grafts and heart valves for pediatric and adult indications.
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Pathways’ Pick of the Week
Pathways' Pick of the Week: MDUFA VI Talks: Sticking Points and Progress
MDUFA VI talks between FDA and industry advance, with some snags. Excerpted from Pathways’ Picks Febraury 11: User Fee Sticking Points, AdvaMed Hire, China Clinical Trial Policy.