FDA Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices
标准简介
Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices[附网盘链接]是FDA发布的FDA标准，适用于United States。标准截图
![Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices[附网盘链接]](/img/20210914103738lph9b.jpg)
标准文档说明
标准文档类型为Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices[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
Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices Guidance for Industry and Food and Drug Administration Staff This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) current thinking 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
This guidance document was developed to notify manufacturers of the recommended endotoxin limit for the release of intraocular devices and single-use intraocular ophthalmic surgical instruments/accessories in an effort to mitigate future Toxic Anterior Segment Syndrome (TASS) outbreaks. TASS is a sterile inflammatory condition localized to the anterior segment of the eye following intraocular surgery. It has been associated with significant decreases in vision and may require additional surgical procedures, including corneal transplants and glaucoma surgery, to resolve some of its sequelae. National outbreaks of TASS have been associated with endotoxin. Devices used inside the eye, including intraocular devices and single-use intraocular ophthalmic surgical instruments/accessories, can potentially be contaminated with endotoxin as part of the manufacturing, sterilization, or packaging processes. This guidance document provides recommendations for endotoxin limits as well as endotoxin testing to manufacturers and other entities involved in submitting premarket applications (PMAs) or premarket notification submissions [510(k)s] for different categories of intraocular devices to aid in the prevention of future outbreaks of TASS. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’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 Agency guidances means that something is suggested or recommended, but not required. 3
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