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FDA Draft Guidance for Industry and FDA Staff In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, ,

Document Type:
Guidance for Industry
This guidance document, written in question and answer format, is intended to assist you2 (the manufacturer, sponsor, applicant, investigator and the IVD device industry in general) in the development of IVD studies, particularly those exempt from most of the requirements of the IDE regulation and to provide

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