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Negócios · 16/05/20131 min de leitura
Medical Devices; General Hospital and Personal Use Monitoring Devices; Classification of the Ingestible Event Marker
Tradução automática local · Idioma original da fonte
Resumo
The Food and Drug Administration (FDA) is classifying the ingestible event marker into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →