美国FDA 指导原则 体外诊断设备的测定迁移研究工业和FDA工作人员指南 英文原版.pdfVIP

Assay Migration Studies for In Vitro Diagnostic Devices Guidance for Industry and FDA Staff Document issued on: April 25, 2013 The draft of this document was issued on January 5, 2009. For questions regarding this document contact Sally Hojvat, PhD, CDRH/OIR/DMD, by phone at (301) 796-5455, or by email at sally.hojvat@ or Marina V. Kondratovich, PhD, CDRH/OIR by phone at (301) 796-6036 or by email at marina.kondratovich@. For questions relating to devices regulated by CBER, contact the Office of Communications, Outreach and Development, CBER at 301-827-1800 or 800-835-4709. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Biologics Evaluation and Research Contains Nonbinding Recommendations Preface Public Comment You may submit written comments and suggestions at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, (HFA-305), Rockville, MD, 20852. Submit electronic comments to . Identify all comments with the docket number FDA-2008-N­ 0642. Comments may not be acted upon by the Agency until the document is next revised or updated. Additional Copies Additional copies are available from the Internet. You may also send an email request to dsmica@ to receive an electronic copy of the guidance, or send a FAX request to 301-847-8149 to receive a hard copy. Please use the document number 1660 to identify the guidance you are requesting. Additional copies of t