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Geschäft · 21.1.20161 Min. Lesezeit
Implanted Blood Access Devices for Hemodialysis; Guidance for Industry and Food and Drug Administration Staff; Availability
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
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.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →