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비즈니스 · 2016. 1. 21.1 분 읽기
Implanted Blood Access Devices for Hemodialysis; Guidance for Industry and Food and Drug Administration Staff; Availability
로컬 자동 번역 · 원본 출처 언어
요약
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Implanted Blood Access Devices for Hemodialysis." This guidance was developed to support the reclassification of the implanted blood access devices for hemodialysis into class II (special controls) and to assist industry in preparing premarket notification (510(k)) submissions for implanted blood access devices for hemodialysis.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →