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Entreprise · 16/05/20131 min de lecture
Medical Devices; General Hospital and Personal Use Monitoring Devices; Classification of the Ingestible Event Marker
Traduction automatique locale · Langue originale de la source
Résumé
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.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →