美国FDA 指导原则 生物指示剂(BI)上市前通知[510(K)]行业和FDA工作人员提交指南 英文原版.pdfVIP

Guidance for Industry and FDA Staff Biological Indicator (BI) Premarket Notification [510(k)] Submissions Document issued on: October 4, 2007 The draft of this document was issued May 21, 2001 This document supersedes FDA Guide for Validation of Biological Indicator Incubation Time, January 1, 1986 For questions regarding this document contact Dr. Sheila Murphey at 240-276-3700 or by email at sheila.murphey@ 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 the Division of Dockets 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 Docket No. 2001D-0193. 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/1320.pdf. 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 (1320) to identify the guidance you are requesting.