FDA Output
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 28.
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Regulatory & Reimbursement
The Digest September 2026
Cyberattacks impact major industry players, Enovis buys eCential Robotics, Abbott secures two FDA clearances, and more.
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Regulatory & Reimbursement
Pathways' Pick of the Week: PMAs’ Electronic Future
FDA takes a step toward mandatory electronic PMAs. Excerpted from Pathways Picks September 21: PMA eSubmissions, GRAIL Panel, China AI Study Guide, and More