fda 有权命令某些医疗器械的制造商建立和维护跟踪其器械的系统 (21 cfr 821)。这是为了确保制造商可以在必要时*将设备从市场上撤下，并通知患者和提供者设备的任何重大问题。
对于其故障很可能造成严重和不利健康后果的设备，需要进行医疗设备跟踪；拟植入人体一年以上；或者是在设备用户设施之外使用的生命维持或生命支持设备。
fda fact sheets: unique device identification (udi) to more effectively identify medical devices through their distribution and use, fda requires devices be identified with a unique device identification (udi) number. a udi is a unique numeric or alphanumeric code that is part of a device's labeling and includes a device identifier, which is specific to a device model, and a production identifier, which includes the production information for that specific device (lot, serial number or expiration date). another component of the udi system is an fda-controlled database that includes a standard set of identifying elements for each udi. this information is publicly available so that users of a medical device can easily look up the information.
上海角宿企业管理咨询有限公司专注于fda510(k),n95认证,tga注册,欧代注册,欧洲自由销售证明,mdr认证,iso13485认证,sfda注册,fda注册等, 欢迎致电 17802157742