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商业 · 2013/5/161 分钟阅读
Medical Devices; General Hospital and Personal Use Monitoring Devices; Classification of the Ingestible Event Marker
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摘要
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.
来源原始语言: Federal Register — Food and Drug Administration打开原始公告 →