In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions Guidance for Industry and FDA Staff June 2010

GUIDANCE DOCUMENT

• Docket Number: FDA-2007-D-0076
• Issued by: Center for Devices and Radiological Health; Center for Biologics Evaluation and Research

The Investigational Device Exemptions (IDE) regulation, Title 21, Code of Federal Regulations (21 CFR) Part 812, sets forth regulatory requirements for studies of investigational devices. Certain investigational IVD device studies (see the Glossary), however, are exempt from most of the provisions of 21 CFR Part 812 (21 CFR 812.2(c)(3)). This guidance document, written in question and answer format, is intended to assist you (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 you with a broad view of the regulatory framework pertaining to the development phase of IVD devices. The information in this guidance document is also pertinent to investigators who participate in IVD studies and to institutional review boards (IRB) that review and approve such studies. The document is intended to facilitate the movement of new IVD technology from the investigational stage to the marketing stage.

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