OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR
نویسندگان
چکیده
The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of premarket approval applications (PMA) for automated external defibrillator (AED) systems, which consist of an AED and those AED accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., pad electrodes, batteries, adapters, and hardware keys for pediatric use). DATES: This order is effective on January 29, 2015. FOR FURTHER INFORMATION CONTACT: Linda Ricci, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 1314, Silver Spring, MD 20993, 301–796– 6325, [email protected]. SUPPLEMENTARY INFORMATION:
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