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 16.
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First Takes
EU Lawmakers Pledge to Prioritize Device Reforms, But Don’t Commit to Timing
The EU Parliament and Council are just starting work on the European Commission’s proposals to comprehensively reform the MDR and IVDR now that translated texts are ready. Leaders from both bodies say they know quick work is needed, but warn the process is unpredictable.
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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 16.