9月20日，FDA正式出臺了舉世矚目的醫療器械監管規則，要求相關產品須標注唯一識別碼（UDI）。UDI規則實施后，器械產品將更容易被跟蹤、監控，及加快召回。

UDI系統具有提高醫療器械不良事件報告的信息質量潛力，這將有助于FDA更快捷的找出產品問題、更好的定向回應以及提高病人的安全。FDA與醫療行業、臨床社區、病人和大眾消費群體都有緊密的合作。

醫學、法學博士Jeffrey Shuren（FDA器械和輻射健康中心主任）表示：“UDI是提高病人安全的標志，讓我們的醫療設備監控系統更加現代化，同時更促進了醫療設備的創新步伐”。

UDI系統包括兩個核心部分。第一部分是器械的唯一識別編號，由GHTF（全球協調組）進行全球唯一賦碼。這些編號包括了批號、型號、生產日期、有效期等信息，以號碼、可掃描的條形碼及英文文本的形式出現，由器械制造商管理。第二部分是可公開查詢的數據庫，里面可檢索除病人信息外的其他數據，由FDA管理。

一旦該新規則全面實施，市場上流通的產品將可被快速、高效地識別。這意味著兩個方面：

1.患者的電子病歷上將顯示使用了哪一個設備。這將提高不良反應事件的報告質量，加快產品召回，保障病人安全。這也有助于醫療保險的結算。

2.器械產品的分銷網絡將納入數據庫。出現問題后，庫存產品亦可迅速召回。另一方面，也可防止假冒偽劣產品流入市場。FDA表示，分銷網絡的數據將是全球性的。

2007版的《聯邦食品藥品化妝品法》修正案當中，已明確將UDI納入監管日程。因會導致部分廠家的合規成本驚人，政商兩方展開了多年的拉鋸，于2012年7月份發布了120天征求意見稿，而后繼續推遲。

FDA在最終版規則中作出了一定的讓步。大多數高風險植入設備將首先開展UDI監管，如心臟起搏器和除顫器。低風險的產品將免除部分或全部UDI，如繃帶等大包裝產品將共同使用一個UDI編碼。（詳細規則請點擊https://www.federalregister.gov/articles/2013/09/24/2013-23059/unique-device-identification-system）

UDI實施后，醫療器械監管將進入信息化、溯源化的新時代。國家藥監局CFDA將于2015年全面實施的藥品電子監管，與UDI規則有異曲同工之處。不同之處在于一個是藥品，一個是更為復雜的醫療器械，且UDI系統可公開查詢。

英文信息：

Today, the U.S. Food and Drug Administration announced a final rule2 for the unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices.
　　The UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA has worked closely with industry, the clinical community and patient and consumer groups in the development of this rule. 
　　“UDI represents a landmark step in improving patient safety, modernizing our postmarket surveillance system for medical devices, and facilitating medical device innovation,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
　　The UDI system consists of two core items. The first is a unique number assigned by the device manufacturer to the version or model of a device, called a unique device identifier. This identifier will also include production-specific information such as the product’s lot or batch number, expiration date, and manufacturing date when that information appears on the label.
　　The second component is a publicly searchable database administered by the FDA, called the Global Unique Device Identification Database (GUDID) that will serve as a reference catalogue for every device with an identifier. No identifying patient information will be stored in this device information center.
　　The FDA plans to phase in the UDI system, focusing first on high-risk medical devices. Many low-risk devices will be exempt from some or all of the requirements in the final rule.
　　Once fully implemented, the UDI system rule is expected to have many benefits for patients, the health care system and the device industry. It will enhance the ability to quickly and efficiently identify marketed devices when recalled, improve the accuracy and specificity of adverse event reports and provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion. It will also offer a clear way of documenting device use in electronic health records and clinical information systems.  
　　“A consistent and clear way to identify medical devices will result in more reliable data on how medical devices are used. In turn, this can promote safe device use by providers and patients as well as faster, more innovative, and less costly device development,” said Shuren.
　　The FDA issued the proposed rule3 requesting input from industry, the clinical community and patient and consumer groups on July 10, 2012.
　　The UDI system builds on current device industry standards and processes, and reflects substantial input from the clinical community and the device industry during all phases of its development. In addition, the FDA worked to reduce the burden on industry by building upon systems already in place. The UDI system is a key component of the National Medical Device PostMarket Surveillance System4 proposed in September 2012.
　　In general, high-risk medical devices (Class III) will be required to carry unique device identifiers on their label and packaging within one year and this number and corresponding device information must be submitted to the new database. Manufacturers will have three years to act for most Class II (moderate risk) devices. Manufacturers of Class I devices not exempt from UDI requirements will have five years to act. 

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