美国FDA 指导原则 统一血液和血液成分容器标签标准的工业认可和使用指南 英文原版.pdfVIP

Guidance for Industry Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels This guidance is for immediate implementation. FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10. 115(g)(4)(i). Submit one set of either electronic or written comments on this guidance at anytime. Submit electronic comments to . Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You should identify all comments with Docket No. FDA-1998-D-0067 (formerly Docket No. 1998D-0965). Additional copies of this guidance are available from the Office of Communication, Outreach and Development (OCOD), 10903 New Hampshire Avenue, Bldg. 71, rm. 7301, Silver Spring, MD 20993-0002, or by calling 1-800-835-4709 or 240-402-7800, or email ocod@, or from the Internet at /BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guida nces/default.htm. For questions on the content of this guidance, contact OCOD at the phone numbers or email address listed above. U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research June 2014 Contains Nonbinding Recommendations Table of Contents I. INTRODUCTION 1 II. BACKGROUND 2 III. FDA REVIEW AND CONCLUSIONS 2 IV. REPORTING REQUIREMENTS FOR LICENSED ESTABLISHMENTS 2 V. SUPLEMENTARY INFORMATION 3 VI. THE VERSION 3.0.0 STANDARD 3