[技术帖] FDA指南定稿：一次性眼内装置的内毒素测试

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FDA Guidance finalised: Endotoxin Testing for Single-Use Intraocular Ophthalmic Devices

FDA指南定稿：一次性眼内装置的内毒素测试

In September 2014, we reported about the FDA guidance draft on Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices. Now, on 17 August, the FDA published the adopted version of that guidance document. The FDA developed this guideline related to the prevention respectively the weakening of future Toxic Anterior Segment Syndrome (TASS) outbreaks. TASS is a sterile inflammatory condition localized in the anterior segment of the eye following intraocular surgery. Former TASS outbreaks have been associated with endotoxin. This guidance provides recommendations for endotoxin limits, especially for devices used inside the eye, including intraocular devices and single-use intraocular ophthalmic surgical instruments, because they can be contaminated with endotoxin as part of the manufacturing, sterilization, or packaging processes.

2014年9月，我们报道了FDA关于一次性眼内装置的内毒素测试指南草案。在今年8月17日，FDA公布了指南的最终稿。FDA建立的本指南与防止未来中毒前节绽合症（TASS）爆发有关。之前的TASS爆发与内毒素有关。本指南给出了内毒素限度的建议，尤其是眼内使用的装置，包括眼内装置和一次性眼内眼外科仪器，因此它们可能会在生产、灭菌或包装过程中受到内毒素的污染。

The recommendations made in this guidance are applicable to devices used within the eye, either as permanent implants or as single-use devices used in intraocular surgery. Endotoxin contamination of reusable manual ophthalmic surgical instruments is outside the scope of this guidance.

本指南中给出的建议适用于眼内用的装置，以及永久植入物，和眼内外科手术用一次性装置。重复使用的人工眼外科仪器内毒素污染不在本指南范围内。

The devices covered are: 装置包括

A. Intraocular Fluids (21 CFR 886.4275, Class III), specifically viscoelastic surgical aid (LZP)

眼内液体（21 CFR 886.4275, III类），尤其是弹性外科手术助剂（LZP）

B. Anterior Segment Solid Devices

眼前节固体装置

1. Intraocular lenses (21 CFR 886.3600, Class III), including

人工晶体(21 CFR 886.3600, III类)，包括

• Intraocular lenses (HQL)

• 人工晶体（HQL）

• Multifocal intraocular lenses (MFK)

• 多焦人工晶体（MFK）

• Phakic intraocular lenses (MTA)

• 有晶状体人工晶体（MTA）

• Toric intraocular lenses (MJP)

• Toric 人工晶体（MJ[]

• Accommodative intraocular lenses (NAA)

• 可调节人工晶体（NAA）

• Implantable miniature telescope (NCJ)

• 植入式微型望远镜（NCJ）

• Iris reconstruction lenses (NIZ)

• 虹膜重建晶体（NIZ）

2. Capsular tension ring devices (Class III), including

囊袋张力环装置（III类），包括

• Endocapsular rings (MRJ)

• 囊袋张力环（MRJ）

3.Glaucoma devices

青光眼装置

• Aqueous shunts (21 CFR 886.3920, Class II), including 房水引流物
  - Eye valve implant (KYF) 眼房水阀植入物

• Other glaucoma devices (Class III) 其它青光眼装置（III类）
  - Intraocular pressure lowering implants (OGO) 眼内压降低植入物

4. Phacofragmentation systems (21 CFR 886.4670, Class II), specifically the accessories of irrigation/aspiration sleeves and tubing (HQC) 超声粉碎系统，尤其是冲洗附件/吸入套和管

More details about the background and the recommendations can be found in the adopted Guidance for Industry and Food and Drug Administration Staff 'Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices'.

更多背景信息和建议参见FDA行业指南