FDA Draft Guidance for Industry Application of the “Solely Engaged” Exemptions in Parts 117 and 507
标准简介
Draft Guidance for Industry Application of the “Solely Engaged” Exemptions in Parts 117 and 507[附网盘链接]由Food&Drug Administration于之前发布，适用于United States。标准截图
![Draft Guidance for Industry Application of the “Solely Engaged” Exemptions in Parts 117 and 507[附网盘链接]](/img/20210914103725dy06f.jpg)
标准文档说明
标准文档类型为Draft Guidance for Industry Application of the “Solely Engaged” Exemptions in Parts 117 and 507[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
Draft-Not for Implementation Application of the “Solely Engaged” Exemptions in Parts 117 and 507: 1
Guidance for Industry This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration's (FDA or we) on this topic.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 it 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 The purpose of this guidance is to help establishments and facilities subject to Title 21 of the Code of Federal Regulations (21 CFR) part 117 (part 117) or 21 CFR part 507 (part 507) determine whether they are “solely engaged” in certain activities. Establishments and facilities “solely engaged” in certain activities are exempt from some or all requirements in parts 117 or 507. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our 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 guidances means that something is suggested or recommended, but not required. II. Background This guidance concerns two regulations that we have established in 21 CFR as part of our 2
implementation of the FDA Food Safety Modernization Act (FSMA; Pub. L. 111–353). These two regulations are part 117 (published in the Federal Register on September 17, 2015, 80 FR 55907) and part 507 (published in the Federal Register on September 17, 2015, 80 FR 51670). 1
This guidance has been jointly prepared by the Office of Food Safety in the Center for Food Safety and Applied Nutrition, the Office of Surveillance and Compliance in the Center for Veterinary Medicine, and the Office of Foods and Veterinary Medicine in the Office of the Commissioner at the U.S. Food and Drug Administration. 2
For more information on the Agency’s implementation of FSMA, see http://www.fda.gov/fsma. 3
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