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

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

Document issued on: June 25, 2010
The draft of this document was issued on October 25, 2007.
This document supersedes "Guidance for FDA Staff: Regulating In Vitro
Diagnostic Device (IVD) Studies," issued December 17, 1999.

For questions regarding this document, contact Sally Hojvat, Ph.D. in CDRH at 301-796-5455 or the Office of Communication, Outreach and Development in CBER at 1-800-835-4709 or 301-827-1800.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

open here to see the entire document:
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071230.pdf