美国FDA 指导原则 行业和FDA员工指南脊柱系统510(K)s(PDF格式) 英文原版.pdfVIP

Guidance for Industry and FDA Staff Spinal System 510(k)s Document issued on: May 3, 2004 This document supersedes “Guidance for Spinal System 510(k)s” dated September 27, 2000. For questions regarding this document contact Mr. Theodore Stevens at 240-276-3676 or by email at theodore.stevens@. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Orthopedic Devices Branch Division of General, Restorative, and Neurological Devices Office of Device Evaluation Contains Nonbinding Recommendations Preface Public Comment Comments and suggestions may be submitted at any time for Agency consideration to Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. 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/636.pdf, or to receive this document by fax, call the CDRH Facts-On-Demand system at 800-899-