美国FDA 指导原则 体外诊断(IVD)设备研究-行业和FDA工作人员的常见问题指南 英文原版.pdfVIP

1 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 2 Preface Additional Copies Additional copies are available from the Internet at: /downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocu ments/ucm071230.pdf, Or, contact: Office of Communication, Outreach and Development, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448 Internet: /BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/defaul t.htm Tel: 800-835-4709 or 301-827-1800 3 Table of Contents I. Background 4 II. Introduction 5 III. General Regulatory Issues 7 IV. Investigational Studies 18 V. Human Subject Protection 22 VI. Data Considerations 25 VII. Glossary 28 VIII. References 35 Appendix 1: REGULATORY DECIS