FDA Draft Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2)
标准简介
Draft Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2)[附网盘链接]是于过去发布的FDA标准，适用于US。标准截图
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标准文档说明
标准文档类型为Draft Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2)[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
Contains Nonbinding Recommendations 1
Draft Guidance for Industry Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2) This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if such approach satisfies the requirements of the applicable statutes and regulations. If you wish to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance. I. Introduction This document represents a draft of the second edition of guidance intended to assist those parties responsible for complying with the Reportable Food Registry requirements prescribed by the Food and Drug Administration Amendments Act of 2007 (Pub. L.110-085). As required by section 1005(f) of this law, in September 2009, FDA issued guidance to industry about submitting reports of instances of reportable food through the electronic portal and providing notifications to other persons in the supply chain of such articles of food. When finalized, this second edition of that guidance document will provide further guidance to industry on those topics and in addition will address inquiries that the agency has received through its Reportable Food Registry help desk and/or by other means since the implementation of the Reportable Food Registry on September 8, 2009. New questions and answers are identified with the date that they were added to the guidance. Questions and answers identified as amended have been changed since their appearance in the earlier version of the guidance in order to improve the guidance’s clarity. Questions and answers that have been altered only in non-substantive ways (e.g., by adding citations or making grammatical changes) are not marked as amended. To facilitate adding new questions and answers to future editions of this guidance without requiring every question and answer to be re-numbered, we have changed the numbering system in this 1
This draft guidance has been prepared by the Office of Food Defense, Communication and Emergency Response in the Center for Food Safety and Applied Nutrition, in cooperation with the Center for Veterinary Medicine, the Office of Regulatory Affairs, the Office of Information Management and the Office of Emergency Operations at the U.S. Food and Drug Administration.
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