ビジネス · 2013/5/161 分で読めます
Medical Devices; General Hospital and Personal Use Monitoring Devices; Classification of the Ingestible Event Marker
ローカル自動翻訳 · 情報源の原言語
概要
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.