{"id":684,"date":"2013-10-04T22:38:38","date_gmt":"2013-10-04T22:38:38","guid":{"rendered":"http:\/\/www.wi.rwth-aachen.de\/SmartMedCN\/?p=684"},"modified":"2013-10-04T22:38:38","modified_gmt":"2013-10-04T22:38:38","slug":"fda-requires-unique-device-identifier-udi","status":"publish","type":"post","link":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/2013\/10\/04\/fda-requires-unique-device-identifier-udi\/","title":{"rendered":"FDA Requires Unique Device Identifier (UDI)"},"content":{"rendered":"

FDA has recently released a final rule requiring that most medical devices distributed in the United States carry a unique device identifier, or UDI. A UDI is a unique numeric or alphanumeric code that consists of two parts:<\/strong><\/p>\n

\u00b7 a device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device, and<\/strong><\/p>\n

\u00b7 a production identifier (PI), a conditional, variable portion of a UDI that identifies batch number, expiration etc.<\/strong><\/p>\n

Besides, FDA is also creating a Database for the public to look up information about the device. (Source: FDA website)<\/strong><\/p>\n

 <\/p>\n

FDA\u6b63\u5f0f\u53d1\u5e03\u533b\u7597\u5668\u68b0UDI\u552f\u4e00\u8bc6\u522b\u7801\u76d1\u7ba1\u89c4\u5219<\/strong><\/p>\n

\u6765\u6e90\uff1a\u7c73\u5185\u7f51\u5668\u68b0\u7ec4<\/p>\n

 <\/p>\n

\u6838\u5fc3\u63d0\u793a\uff1a\u4e0a\u5468\u4e94\uff0cFDA\u6b63\u5f0f\u51fa\u53f0\u4e86\u4e3e\u4e16\u77a9\u76ee\u7684\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u89c4\u5219\uff0c\u8981\u6c42\u76f8\u5173\u4ea7\u54c1\u987b\u6807\u6ce8\u552f\u4e00\u8bc6\u522b\u7801\uff08UDI\uff09\u3002UDI\u89c4\u5219\u5b9e\u65bd\u540e\uff0c\u5668\u68b0\u4ea7\u54c1\u5c06\u66f4\u5bb9\u6613\u88ab\u8ddf\u8e2a\u3001\u76d1\u63a7\uff0c\u53ca\u52a0\u5feb\u53ec\u56de\u3002<\/p>\n

\u7c73\u5185\u7f519\u670822\u65e5\u8baf\uff08\u5510\u5b50\u94a6\uff09\u4e0a\u5468\u4e94\uff0cFDA\u6b63\u5f0f\u51fa\u53f0\u4e86\u4e3e\u4e16\u77a9\u76ee\u7684\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u89c4\u5219\uff0c\u8981\u6c42\u76f8\u5173\u4ea7\u54c1\u987b\u6807\u6ce8\u552f\u4e00\u8bc6\u522b\u7801\uff08UDI\uff09\u3002UDI\u89c4\u5219\u5b9e\u65bd\u540e\uff0c\u5668\u68b0\u4ea7\u54c1\u5c06\u66f4\u5bb9\u6613\u88ab\u8ddf\u8e2a\u3001\u76d1\u63a7\uff0c\u53ca\u52a0\u5feb\u53ec\u56de\u3002<\/p>\n

UDI\u7cfb\u7edf\u5305\u62ec\u4e24\u4e2a\u6838\u5fc3\u90e8\u5206\u3002\u7b2c\u4e00\u90e8\u5206\u662f\u5668\u68b0\u7684\u552f\u4e00\u8bc6\u522b\u7f16\u53f7\uff0c\u7531GHTF\uff08\u5168\u7403\u534f\u8c03\u7ec4\uff09\u8fdb\u884c\u5168\u7403\u552f\u4e00\u8d4b\u7801\u3002\u8fd9\u4e9b\u7f16\u53f7\u5305\u62ec\u4e86\u6279\u53f7\u3001\u578b\u53f7\u3001\u751f\u4ea7\u65e5\u671f\u3001\u6709 \u6548\u671f\u7b49\u4fe1\u606f\uff0c\u4ee5\u53f7\u7801\u3001\u53ef\u626b\u63cf\u7684\u6761\u5f62\u7801\u53ca\u82f1\u6587\u6587\u672c\u7684\u5f62\u5f0f\u51fa\u73b0\uff0c\u7531\u5668\u68b0\u5236\u9020\u5546\u7ba1\u7406\u3002\u7b2c\u4e8c\u90e8\u5206\u662f\u53ef\u516c\u5f00\u67e5\u8be2\u7684\u6570\u636e\u5e93\uff0c\u91cc\u9762\u53ef\u68c0\u7d22\u9664\u75c5\u4eba\u4fe1\u606f\u5916\u7684\u5176\u4ed6\u6570\u636e\uff0c\u7531 FDA\u7ba1\u7406\u3002<\/p>\n

\u4e00\u65e6\u8be5\u65b0\u89c4\u5219\u5168\u9762\u5b9e\u65bd\uff0c\u5e02\u573a\u4e0a\u6d41\u901a\u7684\u4ea7\u54c1\u5c06\u53ef\u88ab\u5feb\u901f\u3001\u9ad8\u6548\u5730\u8bc6\u522b\u3002\u8fd9\u610f\u5473\u7740\u4e24\u4e2a\u65b9\u9762\uff1a<\/p>\n

1.\u60a3\u8005\u7684\u7535\u5b50\u75c5\u5386\u4e0a\u5c06\u663e\u793a\u4f7f\u7528\u4e86\u54ea\u4e00\u4e2a\u8bbe\u5907\u3002\u8fd9\u5c06\u63d0\u9ad8\u4e0d\u826f\u53cd\u5e94\u4e8b\u4ef6\u7684\u62a5\u544a\u8d28\u91cf\uff0c\u52a0\u5feb\u4ea7\u54c1\u53ec\u56de\uff0c\u4fdd\u969c\u75c5\u4eba\u5b89\u5168\u3002\u8fd9\u4e5f\u6709\u52a9\u4e8e\u533b\u7597\u4fdd\u9669\u7684\u7ed3\u7b97\u3002<\/p>\n

2.\u5668\u68b0\u4ea7\u54c1\u7684\u5206\u9500\u7f51\u7edc\u5c06\u7eb3\u5165\u6570\u636e\u5e93\u3002\u51fa\u73b0\u95ee\u9898\u540e\uff0c\u5e93\u5b58\u4ea7\u54c1\u4ea6\u53ef\u8fc5\u901f\u53ec\u56de\u3002\u53e6\u4e00\u65b9\u9762\uff0c\u4e5f\u53ef\u9632\u6b62\u5047\u5192\u4f2a\u52a3\u4ea7\u54c1\u6d41\u5165\u5e02\u573a\u3002FDA\u8868\u793a\uff0c\u5206\u9500\u7f51\u7edc\u7684\u6570\u636e\u5c06\u662f\u5168\u7403\u6027\u7684\u3002<\/p>\n

2007\u7248\u7684\u300a\u8054\u90a6\u98df\u54c1\u836f\u54c1\u5316\u5986\u54c1\u6cd5\u300b\u4fee\u6b63\u6848\u5f53\u4e2d\uff0c\u5df2\u660e\u786e\u5c06UDI\u7eb3\u5165\u76d1\u7ba1\u65e5\u7a0b\u3002\u56e0\u4f1a\u5bfc\u81f4\u90e8\u5206\u5382\u5bb6\u7684\u5408\u89c4\u6210\u672c\u60ca\u4eba\uff0c\u653f\u5546\u4e24\u65b9\u5c55\u5f00\u4e86\u591a\u5e74\u7684\u62c9\u952f\uff0c\u4e8e2012\u5e747\u6708\u4efd\u53d1\u5e03\u4e86120\u5929\u5f81\u6c42\u610f\u89c1\u7a3f\uff0c\u800c\u540e\u7ee7\u7eed\u63a8\u8fdf\u3002<\/p>\n

FDA\u5728\u6700\u7ec8\u7248\u89c4\u5219\u4e2d\u4f5c\u51fa\u4e86\u4e00\u5b9a\u7684\u8ba9\u6b65\u3002\u5927\u591a\u6570\u9ad8\u98ce\u9669\u690d\u5165\u8bbe\u5907\u5c06\u9996\u5148\u5f00\u5c55UDI\u76d1\u7ba1\uff0c\u5982\u5fc3\u810f\u8d77\u640f\u5668\u548c\u9664\u98a4\u5668\u3002\u4f4e\u98ce\u9669\u7684\u4ea7\u54c1\u5c06\u514d\u9664\u90e8\u5206\u6216\u5168\u90e8UDI\uff0c\u5982\u7ef7\u5e26\u7b49\u5927\u5305\u88c5\u4ea7\u54c1\u5c06\u5171\u540c\u4f7f\u7528\u4e00\u4e2aUDI\u7f16\u7801\u3002\uff08\u8be6\u7ec6\u89c4\u5219\u8bf7\u70b9\u51fbhttps:\/\/www.federalregister.gov\/articles\/2013\/09\/24\/2013-23059\/unique-device-identification-system\uff09<\/p>\n

UDI\u5b9e\u65bd\u540e\uff0c\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u5c06\u8fdb\u5165\u4fe1\u606f\u5316\u3001\u6eaf\u6e90\u5316\u7684\u65b0\u65f6\u4ee3\u3002\u56fd\u5bb6\u836f\u76d1\u5c40CFDA\u5c06\u4e8e2015\u5e74\u5168\u9762\u5b9e\u65bd\u7684\u836f\u54c1\u7535\u5b50\u76d1\u7ba1\uff0c\u4e0eUDI\u89c4\u5219\u6709\u5f02\u66f2\u540c\u5de5\u4e4b\u5904\u3002\u4e0d\u540c\u4e4b\u5904\u5728\u4e8e\u4e00\u4e2a\u662f\u836f\u54c1\uff0c\u4e00\u4e2a\u662f\u66f4\u4e3a\u590d\u6742\u7684\u533b\u7597\u5668\u68b0\uff0c\u4e14UDI\u7cfb\u7edf\u53ef\u516c\u5f00\u67e5\u8be2\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"

FDA has recently released a final rule requiring that most medical devices distributed in the United States carry a unique device identifier, or UDI. A UDI is a unique numeric […]<\/p>\n","protected":false},"author":951,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"c2c_always_allow_admin_comments":false,"footnotes":""},"categories":[2],"tags":[21,22,28],"class_list":["post-684","post","type-post","status-publish","format-standard","hentry","category-government-news","tag-information-system","tag-legislation","tag-standards"],"_links":{"self":[{"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/posts\/684","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/users\/951"}],"replies":[{"embeddable":true,"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/comments?post=684"}],"version-history":[{"count":0,"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/posts\/684\/revisions"}],"wp:attachment":[{"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/media?parent=684"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/categories?post=684"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/tags?post=684"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}