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关于FDA唯一器械标识(UDI)系统第三阶段的法规要求,你必须知道什么?

来源: 时间:2017-12-25 21:39:00

美国FDA正在分阶段进行唯一器械标识 (UDI) 系统的实施工作。目前,所有III类医疗器械、植入性器械、支持生命和维持生命的器械都必须加印UDI标识。2016年9月24日之前将进行系统下一阶段 的施行工作。自2016年9月24日起,所有II类医疗器械在分销前必须依法加印UDI标识。此外,预期用于特定用途的III类医疗器械以及美国公共卫生 部(Public Health Service,PHS)特许的器械必须在器械上直接标识UDI。

美国FDA正在分阶段进行唯一器械标识 (UDI) 系统的实施工作。目前,所有III类医疗器械、植入性器械、支持生命和维持生命的器械都必须加印UDI标识。2016年9月24日之前将进行系统下一阶段 的施行工作。自2016年9月24日起,所有II类医疗器械在分销前必须依法加印UDI标识。此外,预期用于特定用途的III类医疗器械以及美国公共卫生 部(Public Health Service,PHS)特许的器械必须在器械上直接标识UDI。


关于FDA唯一器械标识(UDI)系统第三阶段的法规要求,你必须知道什么?


UDI 系统为医疗器械提供一个唯一代码。FDA希望,在不良事件报告、上市后分析、器械召回和库存文档管理的情况下,该系统能够更加有效和准确地识别器械。 FDA将具有中度风险的器械归为II类医疗器械。也就是说,现行的方法和控制手段无法确保产品的有效性和安全性。避孕套、输液泵和电动轮椅都是II类医疗 器械的例子。要想确认你的产品是否为II类医疗器械,可以查阅FDA的器械分类指导网站。

UDI是医疗器械唯一的数字或字母代码,并且应加印于器械标签的右下方。UDI可以包括纯文本(人可读),也可以采用自动识别和数据采集(AIDC)技术(机器可读)。UDI由两部分组成:强制性的器械标识符(DI)和受条件限制的生产标识符(PI)。

UDI中的PI部分标示以下一项或几项器械特性:
1.批号
2.序列号
3.有效期
4.生产日期
5.独特识别码(用于人类细胞和组织)

全球唯一医疗器械标识数据库(GUDID)只存储DI的信息,不存储PI的信息。不过,PI标记可以标示器械标签上所显示的条件性的PI特征。

不到4个月,FDA就要实施第三阶段的UDI系统,II类器械的企业必须确保采取措施,为其产品建立UDI。首先,必须聘请一家认可的签发机构。该签发机构 生成用于UDI的唯一贴标商代码。然后,必须将UDI加印在标签和包装上。对于那些可重复使用并且每次使用前需重新处理的器械,必须在器械上直接标识 UDI。(这一点在FDA的21 CFR 801.45有所阐述)。最后,这些数据必须输入GUDID数据库,而且任何变动都应该被保存下来。

豁 免UDI规则要求的器械包括便利包里的器械。换言之,只要便利包本身的标签加印了UDI,那么便利包内直接包装的器械就不需要UDI标识。急救药箱就是一 个例子;但包装在一起的可重复使用医疗器械却非如此。同样,单个的一次性使用器械在使用前被放在一个包装分销的,无需遵循UDI标识要求。这里的豁免情况 不适用于植入性医疗器械。(有关豁免的进一步信息可以参考FDA的21 CFR 801.30。)更多有关UDI系统的一般信息,请访问FDA网站。


英语原文



What do you need to know to comply with Phase 3 of FDA’s Unique Device Identification System?


The FDA is in the process of implementing the Unique Device Identification (UDI) System in a series of phases. Currently, all Class III and implantable, life-supporting and life-sustaining medical devices require UDIs. The next phase of the system will be implemented by September the 24th, 2016. After this date, all Class II medical devices will legally require UDI labels before product distribution. Additionally, Class III devices and PHS-licensed devices intended for certain uses will require direct marking.

The UDI System provides a unique code for the medical device. The FDA hopes this will lead to more efficient and accurate identifying of devices in the case of adverse event reporting, post-market analysis, managing device recalls and inventory documentation. A medical device is considered Class II by the FDA if the device is of moderate risk. That is, existing methods and controls cannot assure the effectiveness and safety of the product. Condoms, infusion pumps, and powered wheelchairs are examples of Class II devices. To see if your product may classify as a Class II device, visit the FDA device classification guidance site.

The UDI is a numeric or alphanumeric code unique to the medical device that should be placed at the bottom right of the device label. It may consist of plain text (human readable) and AIDC (machine readable). Two parts form the UDI: the mandatory device identifier (DI) and the conditional production identifier (PI).

The PI portion of the UDI identifies one or more of the following device features:
1.Lot or batch number
2.Serial number
3.Expiration date
4.Manufacturing date
5.Distinct Identification Code (For Human Cell and Tissue)

The Global Unique Device Identification Database (GUDID) will store only the DI, and not the PI. However, PI flags may indicate the conditional PI features shown on the device label.

With less than 4 months for the implementation of the FDA’s third phase of the UDI system, companies with Class II devices need to ensure steps are taken to establish UDI for their products. Firstly, an accredited Issuing Agency must be hired. The Issuing Agency develops the unique labeler code for use in UDIs. The UDI must then be placed on the label and package. For reusable devices and those reprocessed between patient use, direct marking may be necessary. (This is clarified under the FDA’s 21 CFR 801.45). Lastly, the data must be entered into GUDID and maintained should any changes occur.

Exceptions to the UDI rule include devices found in convenience kits. That is, the devices found within the immediate packaging of a convenient kit do not require UDI labels, so long that the convenient kit itself is labeled. A first aid kit is an example of a convenient kit; reusable medical devices packaged together are not. Similarly, individual single-use devices that are distributed together in a single package until use are exempt from the UDI label requirements. This exception does not apply implantable devices. (Further exceptions can be found under the FDA’s 21 CFR 801.30.) For more information on the UDI system in general, visit the FDA site.

来自:MedCity News

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