FDA Proposes Unique Device Identifier System for Medical Devices
2012年7月3日，FDA提议为美国大多数的医疗器械唯一设备标识系统。 2007年，美国国会通过了《食品药品管理法修正案（FDAAA）》以对《食品，药品，化妆品法案(FD&C Act)》进行修正。《修正案》第226节要求FDA为医疗器械建立唯一设备识别标识颁布法规。 在这些提议中，唯一设备识别标识将会包括如下内容： 一个设备标识符，一个唯一的数字，或者一串字母与数字结合的字符串；...
View ArticleTop 10 Changes to U.S. FDA Medical Device Registrations and Listings
新版美国食品药品监督管理局（FDA）安全和创新法案（简称FDASIA）加入了多项强制执行的医疗器械企业注册和产品列明的新要求，将于从2012年10月1日开始生效。为了更好的协助医疗器械企业注册，Registrar Corp 列出以下十项医疗器械行业专业人士最需了解的有关FDASIA的最新要求： 在医疗器械产品首次列名和注册年度更新时，医疗器械企业至少必须报告该项医疗器械产品的专有名。...
View ArticleRegistrar Corp to Present UDI Regulation Seminar at FIME 2014
On August 6, Registrar Corp is heading to Miami, Florida to host a seminar about the U.S. Food and Drug Administration (FDA) Unique Device Identification (UDI) regulation at FIME’s 24th Annual...
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FDA Publishes Draft Guidance for UDI Direct Marking
On June 23, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance regarding the placement of unique device identifiers (UDIs) directly onto devices. Most devices will soon be...
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How Many Unique Device Identifiers (UDIs) Will You Need?
You may be surprised by the number of different Unique Device Identifiers (UDIs) a company may need for a single type of device. A separate UDI is needed for certain variables, such as: Size Color...
View ArticleFDA Publishes FY 2016 Medical Device and Generic Drug User Fees
In early August each year, the U.S. Food and Drug Administration (FDA) publishes various user fee rates for the upcoming fiscal year (October 1 to September 30). On August 3, 2015, FDA published its...
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