美国FDA 指导原则 为扩大腹腔镜术设备准备上市前通知的指南(ELD)(PDF格式) 英文原版.pdfVIP

This guidance was written prior to the February 27, 1997 implementation of FDA’s Good Guidance Practices, GGP’s. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP’s. DRAFT GUIDANCE FOR THE PREPARATION OF A PREMARKET NOTIFICATION FOR EXTENDED LAPAROSCOPY DEVICES (ELD) August 30, 1994 (reformatted 12/17/97) This guidance document may contain references to addresses and telephone numbers that are now obsolete. The following contact information is to be used instead: • While this guidance document represents a final document, comments and suggestions may be submitted at any time for Agency consideration to the General Surgical Devices Branch, 9200 Corporate Blvd., HFZ-410, Rockville, MD 20850. • For questions regarding the use or interpretation of this guidance, contact the General Surgical Devices Branch at 301- 594-1307. • 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. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Center for Devices and Radiological Health