美国FDA 指导原则 神经血栓摘除设备的临床前和临床研究行业和FDA工作人员指南 英文原版.pdfVIP

Guidance for Industry and FDA Staff Pre-Clinical and Clinical Studies for Neurothrombectomy Devices Document issued on: June 18, 2007 For questions regarding this document contact Carlos Peña, Ph.D., M.S., at (301) 827-3340 or carlos.pena@ or Neil Ogden at (240) 276-3600 or neil.ogden@. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health General Surgery Devices Branch Division of General, Restorative, and Neurological Devices Office of Device Evaluation Contains Nonbinding Recommendations Preface Public Comments Written comments and suggestions may be submitted at any time for Agency consideration to the Division of Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. Alternatively, electronic comments may be submitted to /dockets/ecomments. When submitting comments, please refer to the exact title of this guidance document. 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 at: /cdrh/ode/guidance/1586.html. You may also send an e-mail request to dsmica@ to receive an electronic copy of the guidance or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number (1586) to identify the guidance you are requesting. Contains Nonbinding Recommendations Table