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Zdrowie i gospodarka · 28.10.2020

Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date; Immediately in Effect Guidance for Industry, Stakeholders, Health Care Professionals, and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date." FDA is issuing this guidance to revise its compliance policy regarding the deadline for filing premarket approval (PMA) applications for previously cleared accessories necessary to the operation of automated external defibrillator (AED) systems.

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