Tag Archives:guidance document

vwin889

2月26日,英国药品和保健品管理局(MHRA)发布了进一步的指导意见(可在此处获得),规定了英国医疗器械的预期监管。should the UK leave the EU without a deal (Guidance).  This Guidance will apply from ‘exit day' (expected to be 11 p.m.2019年3月29日)以……为准。 vwin889

vwim德赢

2月1日,2019,食品和药物管理局发布了一份最终指南[1],为某些理解良好的设备建立了一个可选的510(k)路径。This "Safety and Performance Based Pathway," an expansion of the longstanding Abbreviated 510(k) program,is part of FDA's ongoing effort to modernize and strengthen the 510(k) program.这条通道将继续需要识别…… vwim德赢

FDA Issues New 德赢真人视讯Draft Guidance on Class Labeling of Companion Diagnostics for Oncology Therapeutic Products

On December 6,FDA专员Gottlieb在一份新闻稿中宣布了一份新的指南草案的可用性,标题为:德赢真人视讯“为特定组或类别的肿瘤治疗产品开发和标记体外辅助诊断设备”(指南草案)。德赢真人视讯该机构还在12月7日的《联邦公报》上公布了指导性公告草案。德赢真人视讯FDA发布… 继续阅读

美国食品药品监督管理局发布了两份未包含在产品标签中的通信指南。

上个月,FDA发布了两个关于医疗产品通信的最终指导方针,包括医疗器械公司关于未经批准/批准的医疗产品使用的通信:“与FDA的医疗产品通信要求标签问题和答案”(CWL指南)和“药品和器械制造商与付款人的通信,公式编制委员会,以及类似实体的问题和答案“(付款方指南)。合在一起,… 继续阅读

国家食品药品监督管理总局和社区管理医疗机德赢真人视讯构发布了《罕见疾病医疗器械指南草案》

2月6日,2018,the China Food and Drug Administration (CFDA) and its Center for Medical Device Evaluation (CMDE) issued a 德赢真人视讯draft guidance entitled "Guidance on the Review of Medical Devices for Preventing and Treating Rare Diseases." The draft guidance is based on the reform measures recently outlined in the government's broad blueprint for drug … 继续阅读

FDA Releases 德赢真人视讯Draft Guidance on Dissemination of Patient-Specific Information by Device Manufacturers

上个月,FDA发布了一份关于共享医疗器械相关患德赢真人视讯者特定数据的指导文件草案,包括记录的信息,stored,处理,retrieved,和/或源于该设备。FDA指出,患者越来越多地寻求在自己的医疗保健中发挥积极作用,并向患者提供有关医疗的信息…… 继续阅读

FDA Releases 德赢真人视讯Draft Guidance on the Use of EHRs in Clinical Investigations

5月17日,2016,FDA发布了指导草案,德赢真人视讯鼓励临床研究人员使其电子数据采集(EDC)系统与医疗机构的电子健康记录(ehrs)具有互操作性。虽然EHR通常由医疗保健机构和机构(而不是由FDA监管的实体,如赞助商)控制,when records are used in clinical investigations,FDA … 继续阅读

奥巴马政府发布了其精确医学倡议的最终数据安全政策原则和框架。

As the White House continues to build out the details for the Precision Medicine Initiative ("PMI"),on May 25,2016 it released a final set of principles on data security.  In a document that "provides a broad framework for protecting participants' data and resources in an appropriate and ethical manner," eight overarching data security policy … 继续阅读

动力输出更新主题合格性指南

本月早些时候,the United States Patent and Trademark Office ("PTO") issued an update to its Interim Guidance on patent subject matter eligibility under 35 U.S.C.§ 101.The May 2016 update is the latest in a series of guidance documents regarding subject matter eligibility issued by the PTO over the past two years.  It … 继续阅读

FDA发布了关于在临床德赢真人视讯调查中使用电子知情同意书的指导草案。

On March 9,FDA宣布提供了一份指导文件草案,重点是在临床调查中使用电子知情同意书(德赢真人视讯EIC)。该文件为调查人员提供了建议,sponsors,and institutional review boards (IRBs) concerning eIC,which refers to "using electronic systems and processes that may employ multiple electronic media (e.g.,文本,绘图,… 继续阅读

FDA Finalizes Guidance Limiting Oversight of Certain Software Devices

On February 9,2015,FDA发布了最终指导文件“医疗器械数据系统,医疗图像存储设备,and Medical Image Communications Devices," in which the agency finalized a deregulatory policy for certain software devices.  FDA's new guidance document largely confirms the enforcement policies set forth in the 德赢真人视讯draft guidance document FDA issued in July … 继续阅读

CDRH发布2015年指导文件议程,宣布回顾性指导文件审查

1月9日,FDA公布了一个网站的可用性,该网站包括两个指导文件列表,设备和放射卫生中心(“CDRH”或“中心”)计划在2015财年(“FY”)发布。第一个是机构“完全打算”发布的指导文件草案和最终清单(以下简称“指南文件”)。德赢真人视讯 继续阅读

关于边境医疗设备的新MHRA指南

In February 2014,the MHRA published new guidance on borderline medical devices.  The guidance considers only medical devices within the terms of the Medical Device Directive and not the Active Implantable Medical Devices Directive or In Vitro Medical Devices Directive.Purpose and mode of action The MHRA makes clear that borderline determinations "will be based … 继续阅读

FDA最终确定了CDRH上诉程序指南,发布关于第51德赢真人视讯7A节的指导草案

5月17日,2013,食品和药物管理局采取重大措施更新其医疗器械上诉程序。首先,FDA finalized its guidance on CDRH Appeals Processes,其中“描述了外部利益相关者要求对CDRH员工的决定或行动进行额外审查的过程。”其次,FDA发布了一份关于问题和答案的新德赢真人视讯指南草案… 继续阅读
LexBlog