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비즈니스 · 2016. 11. 18.1 분 읽기

Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

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요약

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices." This guidance provides a detailed description of the information that should be included in a premarket notification for a magnetic resonance diagnostic device (MRDD).

원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →