美国FDA 指导原则 行业指南和FDA工作人员视网膜假体研究设备豁免(IDE)指南(Pdf) 英文原版.pdfVIP

Investigational Device Exemption (IDE) Guidance for Retinal Prostheses Guidance for Industry and Food and Drug Administration Staff Document issued on: March 6, 2013 The draft of this document was issued on April 17, 2009. For questions regarding this document contact Ethan Cohen, Ph.D. at 301-796-2485, ethan.cohen@ (OSEL) or Bernard Lepri, OD, MS, M.Ed. at 301-796-6501, bernard.lepri@ (ODE). U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Office of Science and Engineering Laboratories Office of Device Evaluation 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 listed in the notice of availability that publishes in the Federal Register . 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 e-mail 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 1809 to identify the guidance you are requesting. Contains Nonbinding Recommendations Table of Contents 1. Introduction 2 2. Scope 3 3. Device Description