Diese Übersetzung wird noch vorbereitet. Bis dahin zeigen wir vorübergehend die englische Originalversion.
Geschäft · 1.8.20031 Min. Lesezeit
Medical Devices; Guidance for Industry and FDA Staff; Implantable Middle Ear Hearing Device; Availability
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Guidance for Industry and FDA Staff; Implantable Middle Ear Hearing Device." This guidance document represents the agency's current thinking on the technical content and clinical considerations for a premarket approval application (PMA) for an implantable middle ear hearing device (IMEHD). This guidance provides information to consider for developing the clinical studies and generating the scientific evidence that will provide reasonable assurance of safety and effectiveness of the IMEHD for its intended use.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →