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 21.
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Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in September 2026. Updated September 21.
This month, consumer tech giants acquire or partner to put core skill sets to use for medical applications; two private equity deals signal what's hot; and Curium, curiously, creates a radiopharmaceuticals giant.
The country amends its regulations to further rely on EU CE marks, and makes other simplifications. Excerpted from Pathways Picks August 26: India Harmonization, Digital Health Updates, FDA Home Challenge, and More.