FDA Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use - Compliance Policy
标准简介
Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use - Compliance Policy[附网盘链接]是FDA发布的FDA标准，适用于United States。标准截图
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标准文档说明
标准文档类型为Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use - Compliance Policy[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use – Compliance Policy Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance addresses the regulatory requirements for determining donor eligibility that apply to establishments that collect blood and blood components (blood establishments) intended solely for autologous use. On May 22, 2015, in order to better assure the safety of the nation’s blood supply and to help protect donor health, FDA finalized its revision of the applicable requirements for blood establishments to test donors for infectious disease, and to determine that donors are eligible to donate and that donations are suitable for transfusion or further manufacture (Requirements for Blood and Blood Components Intended for Transfusion or for 1
Further Manufacturing Use, 80 FR 29842 (donor eligibility rule) ). The donor eligibility rule includes requirements related to current good manufacturing practice, donation testing, donor eligibility, and donation suitability (in 21 CFR Parts 606, 610, 630, and 640). It became 2
effective on May 23, 2016. FDA has developed this guidance in response to questions from blood establishments concerning the applicability of the donor eligibility rule to autologous donations. The guidance explains the conditions under which FDA does not intend to take regulatory action for a blood establishment’s failure to comply with certain donor eligibility determination requirements in collecting blood and blood components intended solely for autologous use. In general, FDA’s guidance documents, including this guidance document, do not establish legally-enforceable responsibilities. Instead, guidance documents describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA’s guidance documents means that something is suggested or recommended, but not required. 1
https://www.gpo.gov/fdsys/pkg/FR-2015-05-22/html/2015-12228.htm. 2
Unless otherwise specified, all regulation citations refer to the requirements in the donor eligibility rule that became effective May 23, 2016.
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