美国FDA 指导原则 食道和气管假体上市前通知内容的行业指南(PDF格式) 英文原版.pdfVIP

Guidance for Industry GUIDANCE FOR THE CONTENT OF PREMARKET NOTIFICATIONS FOR ESOPHAGEAL AND TRACHEAL PROSTHESES Document issued on: April 28, 1998 U.S. Department Of Health And Human Services Food and Drug Administration Center for Devices and Radiological Health Plastic and Reconstructive Surgery Devices Branch Division of General and Restorative Devices Office of Device Evaluation Preface Public Comment Comments and suggestions may be submitted at any time for Agency consideration to the Plastic and Reconstructive Branch, HFZ-410, 9200 Corporate Boulevard, Rockville, MD 20850. Comments may not be acted upon by the Agency until the document is next revised or updated. For questions regarding the use or interpretation of this guidance contact Stephen Rhodes at (301) 594-3090 or by electronic mail at spr@. Additional Copies To contact the Division of Small Manufacturers Assistance (DSMA), call 800-638-2041 or 301- 443-6597; fax 301-443-8818; email dsmo@; or write to DSMA (HFZ-200), Food and Drug Administration, 1350 Piccard Drive, Rockville, Maryland 20850-4307. FACTS-ON- DEMAND (800-899-0381 or 301-827-0111) and the World Wide Web (CDRH home page: /cdrh/index.html) also provide easy access to the latest information and operating policies and procedures. Please specify number 006 when prompted for the document shelf number. Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses This document reflects the current review guidance for esophageal and tracheal prostheses devices. It is