FDA CPG Sec. 280.100 - Stability Requirements - Licensed In Vitro Diagnostic Products
标准简介
CPG Sec. 280.100 - Stability Requirements - Licensed In Vitro Diagnostic Products[附网盘链接]是FDA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CPG Sec. 280.100 - Stability Requirements - Licensed In Vitro Diagnostic Products[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
Compliance Policy Guide CPG Sec. 280.100: Stability Requirements - Licensed In Vitro Diagnostic Products Guidance for FDA Staff 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 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 Compliance Policy Guide (CPG) is to provide guidance to FDA staff on stability studies for in vitro diagnostic products (IVDs) licensed by the Center for Biologics Evaluation and Research (CBER). In general, FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances 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 guidances means that something is suggested or recommended but not required. II. BACKGROUND: In vitro diagnostic products may be approved or cleared through the medical device authorities of the Federal Food, Drug, and Cosmetic Act or licensed under the Public Health Service Act, depending on their intended use and active substances. Licensed IVDs must meet the requirements in the Quality System Regulation at Title 21 of the Code of Federal Regulations (CFR) Part 820, the provisions for in vitro diagnostic products in 21 CFR Part 809, the requirements in the biologics regulations at 21 CFR Parts 600-660, and the requirements in the approved biologics license application (BLA) for the particular product at 21 CFR Part 601. IVDs regulated as biological products are subject to a number of different provisions that pertain to stability testing prior to product approval. The regulations for biological products require that data establishing the stability of the product through the dating period be included in the BLA (21 CFR 601.2(a)). The IVD regulations, at 21 CFR 809.10(a)(5) and (b)(5)(iv), require that the 1
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