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비즈니스 · 2011. 12. 20.1 분 읽기
Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices; Availability
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요약
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices." This document describes FDA's intent with regard to enforcement of premarket notification (510(k)) requirements for certain in vitro diagnostic and radiology devices under the regulations.
원본 출처 언어: Federal Register — Health and Human Services원문 발표 열기 →