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Zdrowie i gospodarka · 03/02/2015

FDA Republishes Final Order on Premarket Approval for Automated External Defibrillator Systems

The Food and Drug Administration is re-publishing a final order requiring the filing of premarket approval applications for automated external defibrillator systems, which were originally published in 2015, to correct an oversight regarding a comment on adverse tissue reactions as a health risk.

Source: Federal Register — Food and Drug AdministrationOpen original release →