{"id":14830,"date":"2020-06-29T13:13:55","date_gmt":"2020-06-29T11:13:55","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=14830"},"modified":"2023-01-24T15:02:02","modified_gmt":"2023-01-24T14:02:02","slug":"fda-guide-on-non-binding-feedback-request-after-inspection","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/en\/2020\/06\/29\/fda-guide-on-non-binding-feedback-request-after-inspection\/","title":{"rendered":"FDA guide on non-binding feedback request after inspection"},"content":{"rendered":"\n<p>The <strong>FDA&nbsp;guide \u201cNonbinding Feedback After Certain FDA Inspections of Device Establishments\u201d <\/strong>explains how an owner, operator or agent responsible for a medical device company may submit a <strong>non-binding feedback <\/strong>request to the FDA with regard to corrective actions to address certain types of inspection observations documented on form 483 by the FDA. <\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/06\/FDA-feedback-non-vincolante-dopo-ispezione-1024x536.png\" alt=\"FDA guide on non-binding feedback request after inspection\" class=\"wp-image-14808\"\/><figcaption>FDA guide on non-binding feedback request after inspection<\/figcaption><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>What inspection observations may meet the legal criteria for non-binding feedback?<\/strong><\/h2>\n\n\n\n<p><strong>Timely resolution of inspection observations is important for the continuous availability of safe and effective devices in the US market. <\/strong>A timely and non-binding feedback may contribute for a faster resolution to the FDA inspection observations. This guide is required by section 702 of the FDA Reauthorization Act (FDARA) of 2017 which amended section 704 of the Food, Drug and Cosmetic Act (FDCA). Particularly, this section states that the request shall describe how one or more observations \u201cinvolve a public health authority\u201d, \u201cinvolve systemic or important actions\u201d or \u201crelate to emerging security issues\u201d. FDA provides the following <strong>examples of observations that may meet the legal criteria for non-binding feedback:<\/strong> <\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>An observation\nrelating to conditions, which, if not addressed, may result in the release of a\nviolent product that may cause death or serious injury;<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>An observation\nconcerning deficiencies in the quality system or subsystem that have or may\ninvolve a non-compliant, violative and\/or defective device;<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>An observation\nrelating to an emerging security problem that, if not solved, may result in the\nrelease of devices which could cause death or serious injury.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Non-binding feedback request and FDA response<\/strong><\/h2>\n\n\n\n<p><strong>The\nnon-binding feedback request must be sent within 15 working days <\/strong>after the issuance of form 483 and it must be\naddressed to the FDA contact responsible for receiving any response to FDA form\n483. The request must indicate the inspection observation for which feedback\nhas been requested, as well as the corrective actions proposed. <strong>&nbsp;<\/strong><\/p>\n\n\n\n<p>After receiving an application, FDA will first determine\nwhether the eligibility criteria are met. Otherwise, within 45 days, FDA will\ninform the applicant that the application is not admissible. If the request\nmeets one of the criteria, <strong>FDA is\nrequired to provide a non-bending feedback within 45 calendar days. <\/strong><\/p>\n\n\n\n<p>Through the feedback, FDA will communicate whether the proposed\ncorrective actions appear adequate, and, if not, it must provide explanations\nto enable corrective actions to be properly carried out. <\/p>\n\n\n\n<p>The FDA feedback does not prevent further regulatory\ncomments or actions. Companies are not required to adhere to the non-binding\nfeedback provided by FDA; they may, in fact, use an alternative approach to\ncorrect inspection observations. <\/p>\n\n\n\n<p><strong>Thema offers services of <\/strong><a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\"><strong>strategic-regulatory consultancy<\/strong><\/a><strong> to companies producing or distributing Medici and IVD devices. <br>Contact us for more information <\/strong><a href=\"mailto:sales@thema-group.it\"><strong>sales@thema-group.it<\/strong><\/a><\/p>\n\n\n\n<p><em>Sources: <\/em> <\/p>\n\n\n\n<p><a href=\"https:\/\/www.fda.gov\/media\/120260\/download\">https:\/\/www.fda.gov\/media\/120260\/download<\/a> <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/nonbinding-feedback-after-certain-fda-inspections-device-establishments\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/nonbinding-feedback-after-certain-fda-inspections-device-establishments<\/a> <\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA&nbsp;guide \u201cNonbinding Feedback After Certain FDA Inspections of Device Establishments\u201d explains how an owner, operator or agent responsible for a  [&#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-14830","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 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA guide on non-binding feedback request after inspection<\/title>\n<meta name=\"description\" content=\"FDA guide on non-binding feedback explains how a medical device company may submit a non-binding feedback request to the FDA after inspection...\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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