mg4355vip8888

【奥译言】FDA 2018开年停摆!最近不需要接见审查官了

2018-01-23 09:47 ?阅读数:3993 标签:奥译言

下载 (9).jpg


伴随美国政府宣告停工,各职能部门纷纷跟随发布停摆公告,FDA也不例外,以下为FDA公告译文。


FDA一直承担重要的公共卫生作用。大家的工作是为美国人民提供更好的方式来改善他们的健康福利,帮助家庭保护好他们的孩子,使消费者能够对他们使用的产品和他们家庭和动物的食品做出安全和健康的选择。大家所有的工作都很重要,但是只有部分工作可以在资金缺失的情况下继续下去。在2018财年拨款或FDA持续性解决方案缺失下,从2018年1月20日开始持续至2018财年拨款或持续解决方案(“失效期”)颁布之日止,部分必要的业务仍会在法律允许下进行,例如解决涉及人类生命安全的迫在眉睫的威胁和由用户结转资金资助的活动。


在这段时间内,FDA将依照法律继续进行一些确保美国公众健康及与安全极度相关的重要活动。这些重要的公共卫生活动将包括:维持核心职能,处理和应对紧急情况 - 如监测和迅速应对与食源性疾病和流感相关的暴发,支撑高风险食品和医疗产品在产品危及消费者和患者的情况下召回,在大家认为公共健康处于危险中时寻求刑事和民事调查,对进口到美国的食品和医疗产品进行筛选以保护消费者和患者避免受有害产品的侵害。重点是,大家还将继续解决FDA一直在努力解决的现有重大公共卫生挑战,包括波多黎各2017年飓风加剧造成持续的盐碱短缺。医疗器械和其他医疗产品安全问题的关键任务监测也将继续进行。


此外,FDA将继续支撑由结转用户费用余额资助的活动,从而能够继续为需要的患者带来新的治疗选择。然而,在财缺期间,FDA将不允许接受2018财年评估的用户费用,直到2018财年FDA批准为止。这意味着FDA将不接受任何2018财年提交的需要在财缺期间提交费用支付的法规文书。



奥咨达服务


FDA 510K 申报服务和周期(含工厂注册和合同范围内产品列名)
FDA De Novo
FDA MD 预提交(Pre-submission)申报服务和周期
FDA PMA申报服务和周期
FDA产品列名 申报服务和周期
FDA豁免510K-服务


英语原文  


FDA 2018 Shutdown Information


The FDA plays a critical public health role. Our work provides Americans with better ways to improve their health and welfare, helps families protect their children, and enables consumers to make safe and healthier choices about the products they use and the foods they feed to their families and animals. All our work is important, but only some of our work is permitted to continue during a lapse in funding. In the absence of either an FY 2018 appropriation or a Continuing Resolution for FDA, beginning on January 20, 2018 and continuing until the date of enactment of an FY 2018 appropriation or Continuing Resolution ("lapse period"), agency operations continue to the extent permitted by law, such as activities necessary to address imminent threats to the safety of human life and activities funded by carryover user fee funds.

During the lapse period, the agency will be continuing vital activities that are critical to ensuring public health and safety in the United States, consistent with the law. The mission critical, public health activities that will continue include, among other things: maintaining core functions to handle and respond to emergencies – such as monitoring for and quickly responding to outbreaks related to foodborne illness and the flu, supporting high-risk food and medical product recalls when products endanger consumers and patients, pursuing criminal and certain civil investigations when we believe public health is at risk, screening the food and medical products that are imported to the U.S. to protect consumers and patients from harmful products, and addressing other critical public health issues. Importantly, we will also continue to address existing critical public health challenges that the FDA has been working on, including the ongoing IV saline shortage that was exacerbated by the 2017 hurricanes in Puerto Rico. Mission critical surveillance for safety concerns with medical devices and other medical products will also continue.

In addition, the FDA will continue to support activities funded by carryover user fee balances, which allows us to continue to bring new therapeutic options to the patients that need them. However, during the lapse period, the FDA will not have legal authority to accept user fees assessed for FY 2018 until an FY 2018 appropriation for the FDA is enacted. This will mean that the FDA will not be able to accept any regulatory submissions for FY 2018 that require a fee payment and that are submitted during the lapse period.

内容来自:FDA

整理翻译:奥咨达


奥咨达翻译服务

奥咨达翻译团队根植于中国,面向,专注为医疗器械领域的企业提供专业、高效的翻译解决方案。翻译领域包括医疗器械的研发、注册、临床、上市后监督、营销、管理、培训等,译稿已涵盖医疗器械领域的所有类型。


奥咨达翻译组联系方式:

邮箱:trans@osmundacn.com

Q  Q:2761773878 (昵称:OSD_trans)



Hi,are you ready?

准备好开始了吗?
那就与大家取得联系吧

有一个医疗器械项目想和大家谈谈吗?您可以填写右边的表格,让大家了解您的项目需求,这是一个良好的开始,大家将会尽快与你取得联系。当然也欢迎您给大家写信或是打电话,让大家听到你的声音!

奥咨达 | 高端mg4355vip8888注册专家

24小时免费咨询热线:

400-6768632

填写您的项目信息

填写完表单后,请点击以下任意一种沟通方式:

?
XML 地图 | Sitemap 地图