美国FDA 指导原则 上市前通知[510(K)]为行业和FDA工作人员提交的化学指标指南(PDF格式) 英文原版.pdfVIP

Guidance for Industry and FDA Staff Premarket Notification [510(k)] Submissions for Chemical Indicators Document issued on: December 19, 2003 The draft of this document was issued January 27, 2003 For questions regarding this document contact Chiu Lin, Ph.D., 240-276-3700. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Infection Control Devices Branch Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Contains Nonbinding Recommendations Preface Public Comment Written comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, 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 Docket No.02D-0525. 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/1420.pdf or to receive this document by fax, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number (1420) followed by the pound sign (#). Follow the remaining voice prompts to complete your request.