İş dünyası · 16.05.20131 dk okuma
Medical Devices; General Hospital and Personal Use Monitoring Devices; Classification of the Ingestible Event Marker
Yerel otomatik çeviri · Kaynağın orijinal dili
Özet
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.