Zdrowie i gospodarka · 06/01/2023

FDA Classifies Powered Insertion System for Cochlear Implant Electrode Array into Class II Special Controls

The FDA has classified the powered insertion system for a cochlear implant electrode array into Class II special controls, aiming to ensure the device's safety and effectiveness while enhancing patients' access to innovative devices.

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

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