{"id":9922,"date":"2019-06-28T14:15:33","date_gmt":"2019-06-28T12:15:33","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=9922"},"modified":"2023-01-24T15:02:05","modified_gmt":"2023-01-24T14:02:05","slug":"convenience-kits-fda-issues-final-guidance-on-udi-marking","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/en\/2019\/06\/28\/convenience-kits-fda-issues-final-guidance-on-udi-marking\/","title":{"rendered":"Convenience Kits: FDA issues final guidance on UDI marking"},"content":{"rendered":"\n<p>Aimed at providing medical device manufacturers clarifications on unique device identification (UDI) marking policies for convenience kits, FDA has finalized its guidance \u201c<em><a href=\"https:\/\/www.fda.gov\/media\/95120\/download\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">Unique Device Identification: Convenience Kits Guidance for Industry and Food and Drug Administration Staff<\/a> <\/em>\u201d on April 26, 2019. <\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2019\/06\/USA_convenience_kits-1024x536.png\" alt=\"\" class=\"wp-image-9918\"\/><figcaption><em>Convenience Kits: FDA issues final guidance on UDI marking<\/em><\/figcaption><\/figure>\n\n\n\n<p>The unique device identification system\nregulations (21 CFR 801.20) require that the label and each device package of\nevery medical device distributed in the United States bear an UDI to facilitate\ntheir identification throughout distribution and use.<\/p>\n\n\n\n<p>The difference between a <strong>convenience kit<\/strong>\n(considered a device in itself, therefore required to bear an UDI only on the\nlabel of its container) and a <strong>medical procedure kit<\/strong> (where each device\nmust comply with applicable UDI labeling, data submission, and direct mark\nrequirements) is illustrated by way of a few concrete examples: <\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>a\nsingle use disposable medical procedure kit is considered a convenience kit. It\ncontains two or more different medical devices packaged together for the <em>convenience<\/em>\nof the user, and respects the requirement to (a) remain packaged together and (b)\nnot be replaced, substituted, repackaged, sterilized, or otherwise processed or\nmodified before being used by an end user;<\/li><li>a\nnon-sterile orthopedic kit is not considered a convenience kit. The reason is\nthat each device contained in is removed from its packaging to undergo\nsterilization prior its use by an end user.<\/li><\/ul>\n\n\n\n<p>The guidance does not apply to combination\nproducts and <em>in vitro<\/em> diagnostics subject to labeling requirements.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Aimed at providing medical device manufacturers clarifications on unique device identification (UDI) marking policies for convenience kits, FDA has finalized its  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2,1513],"tags":[],"class_list":["post-9922","post","type-post","status-publish","format-standard","hentry","category-news-en","category-us-agent-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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