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【奥译言】FDA对低风险器械推迟UDI要求

阅读: 2017年06月09日

【奥译言】FDA对低风险器械推迟UDI要求


美国食品药品监督管理局(FDA)于本月2号通告医疗器械贴标商,推迟对I类和未分类器械的UDI的实行日期。


FDA的UDI要求的首次出台充满了挑战。自从2013年发布最终UDI决议以来,因考虑到很多企业会逾期或因特定的技术难题而无法履行UDI要求,FDA对大量器械推迟了强制实行日期。


然而,许多高风险器械已经实施了UDI要求,包括III类、可植入和支撑/维持生命的器械,例如人工心脏瓣膜和自动体外除颤仪。并且,FDA声称其UDI数据库已包含了来自多达4000个器械贴标商的140万条记录。


推迟I类和未分类器械的符合期限


FDA声明,推迟I类和未分类器械在标签和包装上履行UDI的要求,并且也推迟了向GUDID提交数据的要求,实行日期由原先的2018年9月24日推迟至至2020年9月24日。


FDA针对I类和未分类器械同时也推迟了对直接标记的要求,该要求指,重复使用器械和每次使用前须再次处理的器械应在器械自身体现UDI码。这类器械的UDI实行日期由原先的2020年9月24日推迟至2022年9月24日。


FDA声称此次推迟是为了在大量低风险器械进入该系统前解决高风险器械有关UDI的挑战难题,并且也考虑到了目前大量工厂难以符合原定期限的要求。


FDA写道,“大家认识到了一些需要解决的复杂政策和技术难题,比如如何将UDI应用到包含可植入器械和仪器的医用手术托盘上。因为器械数量之庞大和其丰富的多样性,为贴标商提供准确和及时的支撑对大家来说也是一项挑战。”


下一步,FDA计划针对相关器械出台有关标签自由裁量权、GUDID数据提交、标准日期格式和直接标记要求细则的引导文件。


英语原文  


FDA Delays UDI Requirements for Low-Risk Devices

Posted 05 June 2017 By Michael MezherBy Zachary Brennan

The US Food and Drug Administration (FDA) on Friday notified medical device labelers that it is extending the compliance dates for certain unique device identifier (UDI) requirements for Class I and unclassified devices.


Rollout of FDA's UDI rule has been fraught with challenges. Since issuing the final UDI rule in 2013, FDA has pushed backcompliance dates for a number of devices in response to concerns from companies over meeting deadlines or to address specific technical challenges.


However, UDI requirements are already in effect for many higher-risk devices, including Class III, implantable and life-supporting/life-sustaining devices such as artificial heart valves and automated external defibrillators (AEDs). And, FDA says its Global UDI Database contains 1.4 million records submitted by more than 4,000 device labelers.


Extension for Class I/Unclassified Devices


FDA says it is extending the requirements for Class I and unclassified devices to bear a UDI on their labels and packages, as well as the requirement for those devices to submit data to GUDID, from 24 September 2018 to 24 September 2020.


The agency is also delaying the direct mark requirement for Class I and unclassified devices, which requires devices to bear a UDI on the device itself if the device is reusable and must be reprocessed before each use, from 24 September 2020 to 24 September 2022.


FDA says it is delaying the requirements in order to work out some of the challenges related to UDI for higher-risk devices before the influx of lower-risk devices enter the system, and in response to concerns from industry about meeting the compliance dates.


"We identified complex policy and technical issues that need resolution, such as how UDI applies to products such as medical procedure trays that contain implantable devices and instruments. Providing accurate and timely support to labelers has also been challenging, due to the sheer number and wide diversity of devices," FDA writes.


Going forward, FDA says it is planning to issue a guidance document to detail its enforcement discretion policy for labeling, GUDID data submission, standard date formatting and direct mark requirements for the affected devices.





内容来自:RAPS

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