FDA Draft Guidance for Industry and FDA Staff In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions
Titel:
FDA Draft Guidance for Industry and FDA Staff
In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions
Internet:
Herkunft/Verlag:
Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ , http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM071230.pdf
Dokumentenart:
Leitfaden für die Industrie
Inhalt:
Im Fragen/Antwort Stil gefasster Leitfaden zur Entwicklung von IVD Studien