{"id":4328,"date":"2017-07-19T10:02:35","date_gmt":"2017-07-19T08:02:35","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=4328\/"},"modified":"2023-01-24T14:59:45","modified_gmt":"2023-01-24T13:59:45","slug":"usa-final-guidance-on-medical-device-reporting-for-manufacturers","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/en\/2017\/07\/19\/usa-final-guidance-on-medical-device-reporting-for-manufacturers\/","title":{"rendered":"USA: final guidance on Medical Device Reporting for Manufacturers"},"content":{"rendered":"<p>Last November 8, the FDA issued the final version of the guidance \u201cMedical Device Reporting for Manufacturers\u201d.<\/p>\n<p>Goal of this guidance is to assist medical device Manufacturers in the application of regulatory requirements by reporting adverse events and to allow FDA and immediate action. Furthermore, some of the most common reporting errors are listed and detailed.<\/p>\n<p>At the end and after 20 years (the previous version was issued in 1997), FDA clarifies, explains and comments again the requirements of the 21 CFR 803.<\/p>\n<p>&nbsp;<\/p>\n<p>For further information:<\/p>\n<p><a href=\"http:\/\/www.fda.gov\/ucm\/groups\/fdagov-public\/@fdagov-meddev-gen\/documents\/document\/ucm359566.pdf\">http:\/\/www.fda.gov\/ucm\/groups\/fdagov-public\/@fdagov-meddev-gen\/documents\/document\/ucm359566.pdf<\/a><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Last November 8, the FDA issued the final version of the guidance \u201cMedical Device Reporting for Manufacturers\u201d. Goal of this guidance  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","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],"tags":[],"class_list":["post-4328","post","type-post","status-publish","format-standard","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>USA: final guidance on Medical Device Reporting for Manufacturers - Thema Med<\/title>\n<meta name=\"description\" content=\"Last November 8, the FDA issued the final version of the guidance \u201cMedical Device Reporting for Manufacturers\u201d. Goal of this guidance is to assist...\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"http:\/\/www.thema-med.com\/en\/2017\/07\/19\/usa-final-guidance-on-medical-device-reporting-for-manufacturers\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"USA: final guidance on Medical Device Reporting for Manufacturers - Thema Med\" \/>\n<meta property=\"og:description\" content=\"Last November 8, the FDA issued the final version of the guidance \u201cMedical Device Reporting for Manufacturers\u201d. Goal of this guidance is to assist...\" \/>\n<meta property=\"og:url\" content=\"http:\/\/www.thema-med.com\/en\/2017\/07\/19\/usa-final-guidance-on-medical-device-reporting-for-manufacturers\/\" \/>\n<meta property=\"og:site_name\" content=\"Thema Med\" \/>\n<meta property=\"article:published_time\" content=\"2017-07-19T08:02:35+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-01-24T13:59:45+00:00\" \/>\n<meta name=\"author\" content=\"redazione\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"redazione\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"http:\/\/www.thema-med.com\/en\/2017\/07\/19\/usa-final-guidance-on-medical-device-reporting-for-manufacturers\/#article\",\"isPartOf\":{\"@id\":\"http:\/\/www.thema-med.com\/en\/2017\/07\/19\/usa-final-guidance-on-medical-device-reporting-for-manufacturers\/\"},\"author\":{\"name\":\"redazione\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e\"},\"headline\":\"USA: final guidance on Medical Device Reporting for Manufacturers\",\"datePublished\":\"2017-07-19T08:02:35+00:00\",\"dateModified\":\"2023-01-24T13:59:45+00:00\",\"mainEntityOfPage\":{\"@id\":\"http:\/\/www.thema-med.com\/en\/2017\/07\/19\/usa-final-guidance-on-medical-device-reporting-for-manufacturers\/\"},\"wordCount\":104,\"publisher\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/#organization\"},\"articleSection\":[\"News\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"http:\/\/www.thema-med.com\/en\/2017\/07\/19\/usa-final-guidance-on-medical-device-reporting-for-manufacturers\/\",\"url\":\"http:\/\/www.thema-med.com\/en\/2017\/07\/19\/usa-final-guidance-on-medical-device-reporting-for-manufacturers\/\",\"name\":\"USA: final guidance on Medical Device Reporting for Manufacturers - Thema Med\",\"isPartOf\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/#website\"},\"datePublished\":\"2017-07-19T08:02:35+00:00\",\"dateModified\":\"2023-01-24T13:59:45+00:00\",\"description\":\"Last November 8, the FDA issued the final version of the guidance \u201cMedical Device Reporting for Manufacturers\u201d. Goal of this guidance is to assist...\",\"breadcrumb\":{\"@id\":\"http:\/\/www.thema-med.com\/en\/2017\/07\/19\/usa-final-guidance-on-medical-device-reporting-for-manufacturers\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"http:\/\/www.thema-med.com\/en\/2017\/07\/19\/usa-final-guidance-on-medical-device-reporting-for-manufacturers\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"http:\/\/www.thema-med.com\/en\/2017\/07\/19\/usa-final-guidance-on-medical-device-reporting-for-manufacturers\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.thema-med.com\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"USA: final guidance on Medical Device Reporting for Manufacturers\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#website\",\"url\":\"https:\/\/www.thema-med.com\/en\/\",\"name\":\"Thema Med\",\"description\":\"Quality and Regulatory Affairs for Medical Devices\",\"publisher\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.thema-med.com\/en\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":[\"Organization\",\"Place\"],\"@id\":\"https:\/\/www.thema-med.com\/en\/#organization\",\"name\":\"Thema\",\"alternateName\":\"Thema\",\"url\":\"https:\/\/www.thema-med.com\/en\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png\",\"contentUrl\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png\",\"width\":2440,\"height\":2851,\"caption\":\"Thema\"},\"image\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.linkedin.com\/company\/thema-s-r-l-\/\"],\"mainEntityOfPage\":{\"@id\":\"http:\/\/www.thema-med.com\/en\/2017\/07\/19\/usa-final-guidance-on-medical-device-reporting-for-manufacturers\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e\",\"name\":\"redazione\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g\",\"caption\":\"redazione\"},\"sameAs\":[\"http:\/\/www.thema-med.eu\"],\"url\":\"http:\/\/www.thema-med.com\/en\/author\/emanuele\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"USA: final guidance on Medical Device Reporting for Manufacturers - Thema Med","description":"Last November 8, the FDA issued the final version of the guidance \u201cMedical Device Reporting for Manufacturers\u201d. Goal of this guidance is to assist...","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"http:\/\/www.thema-med.com\/en\/2017\/07\/19\/usa-final-guidance-on-medical-device-reporting-for-manufacturers\/","og_locale":"en_US","og_type":"article","og_title":"USA: final guidance on Medical Device Reporting for Manufacturers - Thema Med","og_description":"Last November 8, the FDA issued the final version of the guidance \u201cMedical Device Reporting for Manufacturers\u201d. Goal of this guidance is to assist...","og_url":"http:\/\/www.thema-med.com\/en\/2017\/07\/19\/usa-final-guidance-on-medical-device-reporting-for-manufacturers\/","og_site_name":"Thema Med","article_published_time":"2017-07-19T08:02:35+00:00","article_modified_time":"2023-01-24T13:59:45+00:00","author":"redazione","twitter_card":"summary_large_image","twitter_misc":{"Written by":"redazione"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"http:\/\/www.thema-med.com\/en\/2017\/07\/19\/usa-final-guidance-on-medical-device-reporting-for-manufacturers\/#article","isPartOf":{"@id":"http:\/\/www.thema-med.com\/en\/2017\/07\/19\/usa-final-guidance-on-medical-device-reporting-for-manufacturers\/"},"author":{"name":"redazione","@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e"},"headline":"USA: final guidance on Medical Device Reporting for Manufacturers","datePublished":"2017-07-19T08:02:35+00:00","dateModified":"2023-01-24T13:59:45+00:00","mainEntityOfPage":{"@id":"http:\/\/www.thema-med.com\/en\/2017\/07\/19\/usa-final-guidance-on-medical-device-reporting-for-manufacturers\/"},"wordCount":104,"publisher":{"@id":"https:\/\/www.thema-med.com\/en\/#organization"},"articleSection":["News"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"http:\/\/www.thema-med.com\/en\/2017\/07\/19\/usa-final-guidance-on-medical-device-reporting-for-manufacturers\/","url":"http:\/\/www.thema-med.com\/en\/2017\/07\/19\/usa-final-guidance-on-medical-device-reporting-for-manufacturers\/","name":"USA: final guidance on Medical Device Reporting for Manufacturers - Thema Med","isPartOf":{"@id":"https:\/\/www.thema-med.com\/en\/#website"},"datePublished":"2017-07-19T08:02:35+00:00","dateModified":"2023-01-24T13:59:45+00:00","description":"Last November 8, the FDA issued the final version of the guidance \u201cMedical Device Reporting for Manufacturers\u201d. Goal of this guidance is to assist...","breadcrumb":{"@id":"http:\/\/www.thema-med.com\/en\/2017\/07\/19\/usa-final-guidance-on-medical-device-reporting-for-manufacturers\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["http:\/\/www.thema-med.com\/en\/2017\/07\/19\/usa-final-guidance-on-medical-device-reporting-for-manufacturers\/"]}]},{"@type":"BreadcrumbList","@id":"http:\/\/www.thema-med.com\/en\/2017\/07\/19\/usa-final-guidance-on-medical-device-reporting-for-manufacturers\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.thema-med.com\/en\/"},{"@type":"ListItem","position":2,"name":"USA: final guidance on Medical Device Reporting for Manufacturers"}]},{"@type":"WebSite","@id":"https:\/\/www.thema-med.com\/en\/#website","url":"https:\/\/www.thema-med.com\/en\/","name":"Thema Med","description":"Quality and Regulatory Affairs for Medical Devices","publisher":{"@id":"https:\/\/www.thema-med.com\/en\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.thema-med.com\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":["Organization","Place"],"@id":"https:\/\/www.thema-med.com\/en\/#organization","name":"Thema","alternateName":"Thema","url":"https:\/\/www.thema-med.com\/en\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/logo\/image\/","url":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png","contentUrl":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png","width":2440,"height":2851,"caption":"Thema"},"image":{"@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.linkedin.com\/company\/thema-s-r-l-\/"],"mainEntityOfPage":{"@id":"http:\/\/www.thema-med.com\/en\/2017\/07\/19\/usa-final-guidance-on-medical-device-reporting-for-manufacturers\/"}},{"@type":"Person","@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e","name":"redazione","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g","caption":"redazione"},"sameAs":["http:\/\/www.thema-med.eu"],"url":"http:\/\/www.thema-med.com\/en\/author\/emanuele\/"}]}},"_links":{"self":[{"href":"http:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/posts\/4328","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/comments?post=4328"}],"version-history":[{"count":1,"href":"http:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/posts\/4328\/revisions"}],"predecessor-version":[{"id":26866,"href":"http:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/posts\/4328\/revisions\/26866"}],"wp:attachment":[{"href":"http:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/media?parent=4328"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/categories?post=4328"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/tags?post=4328"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}