Why is this Unique Device Identification System needed? Ron— Increasing concerns about product recalls, counterfeit devices, and patient safety has led the F-D-A to start the process of developing a U-D-I system. Currently identification methods are fragmented and it’s sometimes difficult to t...
Food and Drug Administration (FDA) to establish a unique device identification system for implementing the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act). It mentions that the system would require inclusion of unique device identifier (UDI) to the label of medical ...
Medical device registration: registration, registration change or filing, the registrant/filer should submit Device Identifier (DI) in the registration/filing management system. Select data carrier*: Give the medical device a single identification data carrier on the smallest sales unit of the medical ...
一、前言开始UDI(Unique Device Identification)标签制作之前,我们要先了解下,在国外,目前FDA接受的UDI编码三家发放机构包括,GS1国际物品编码协会、HIBCC保健业商务通信委员会和ICCBBA国际血库自动化委员会…
For more information on the UDI system, visit Unique Device Identification (UDI) on the FDA website: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ If you have additional questions about how Masimo is complying with UDI regulations, please contact Masimo Cust...
unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. The unique identifier shall adequately identify the device ...
law: The Secretary shall promulgate regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. Th...
医疗器械唯一标志(Unique Device Identification,通称UDI)是医疗器械的身份证件,医疗器械唯一标识系统由医疗器械唯一标志、数据信息媒介和数据库查询构成。由于医疗器械产品风险和监管追溯要求的不同,其器械的UDI也随之不同。器械识别码(DI)属于静态信息,它是医疗器
The Secretary shall promulgate regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. The uniq...
摘要: This Viewpoint describes the Food and Drug Administration鈥檚 unique device identification system for medical devices and recommends that federal agencies, specialty societies, and health care organizations collaborate to ensure that the system鈥檚 potential is fulfilled....