{"id":8073,"date":"2024-01-11T20:04:19","date_gmt":"2024-01-11T20:04:19","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=8073"},"modified":"2024-01-12T20:03:30","modified_gmt":"2024-01-12T20:03:30","slug":"fda-servicing-vs-remanufacturing","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/fda-servicing-vs-remanufacturing\/","title":{"rendered":"How FDA Distinguishes Between Medical Device Servicing and Remanufacturing"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8073\" class=\"elementor elementor-8073\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7388bb3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7388bb3\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4264d41\" data-id=\"4264d41\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-d04a716 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"d04a716\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-e193c4d\" data-id=\"e193c4d\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa22ff3 elementor-widget elementor-widget-post-info\" data-id=\"aa22ff3\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/elementor\/css\/custom-widget-icon-list.min.css?ver=0\"><link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/plugins\/elementor-pro\/assets\/css\/widget-theme-elements.min.css\">\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-7f6be35 elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.orielstat.com\/blog\/2024\/01\/11\/\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\tJanuary 11, 2024\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-25cfb2d elementor-widget elementor-widget-heading\" data-id=\"25cfb2d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">How FDA Distinguishes Between Medical Device Servicing and Remanufacturing\n<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-78a7c7e elementor-widget elementor-widget-image\" data-id=\"78a7c7e\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1650\" height=\"1100\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/11\/Verification-and-Validation.jpg\" class=\"attachment-full size-full wp-image-1223\" alt=\"Fixing Devices\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/11\/Verification-and-Validation.jpg 1650w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/11\/Verification-and-Validation-300x200.jpg 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/11\/Verification-and-Validation-768x512.jpg 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/11\/Verification-and-Validation-1024x683.jpg 1024w\" sizes=\"(max-width: 1650px) 100vw, 1650px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f7a5edb elementor-widget elementor-widget-text-editor\" data-id=\"f7a5edb\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p>Many medical devices eventually require preventative maintenance or repairs, and this vital service can be performed by a manufacturer, health institution, independent servicing organization (ISO), or third-party service company. In a 2018 report, FDA noted that their analysis of comments, complaints, and adverse events revealed that most serious issues were related to devices that had been remanufactured rather than instruments that had been serviced. The difference between the two may seem negligible, but it actually has profound compliance implications. Although FDA believes it has statutory authority to regulate device servicing, it admits that it generally does not enforce the Food, Drug &amp; Cosmetic Act (FD&amp;C) requirements with respect to servicing activities. Remanufacturing is a different story, and therefore FDA&#8217;s interpretation of what constitutes remanufacturing vs. servicing activities is something you should understand.<\/p><h3>\u00a0<\/h3><h3>What&#8217;s the Difference?<\/h3><p>Here&#8217;s how FDA makes the distinction between remanufacturing and servicing:<\/p><ul><li><strong>Remanufacturing<\/strong>\u00a0is the processing, conditioning, renovating, repackaging, restoring, or any other act performed on a finished device that\u00a0<em>significantly changes the finished devices performance or safety specifications, or intended use<\/em>.<\/li><li><strong>Servicing<\/strong> is the repair and\/or preventive or routine maintenance of one or more parts in a finished device, after distribution, for purposes of <em>returning it to the safety and performance specifications established by the OEM to meet its original intended use<\/em>.<\/li><\/ul><p>Because FDA considers remanufacturers to be manufacturers, you&#8217;ll want to make sure you understand the boundaries of servicing a device. In June 2021, FDA released a draft guidance document entitled <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/remanufacturing-medical-devices\" target=\"_blank\" rel=\"noopener noreferrer\">Remanufacturing of Medical Devices<\/a>\u00a0in which they give examples of what is considered remanufacturing. The difference comes down to these guiding questions:<\/p><p>1 \u2013 Have any modifications resulted in a change to the intended use?<\/p><p>2 \u2013 Have any activities changed the safety or performance specifications of the finished device?<\/p><p>3 \u2013 Do any changes warrant a new FDA submission\u2019<em>\u00a0(See this\u00a0<\/em><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/deciding-when-submit-510k-change-existing-device\" target=\"_blank\" rel=\"noopener noreferrer\"><em>FDA guidance document<\/em><\/a><em>\u00a0on deciding when submit a 510(k) for a changed existing device, or\u00a0<\/em><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/deciding-when-submit-510k-software-change-existing-device\" target=\"_blank\" rel=\"noopener noreferrer\"><em>this one<\/em><\/a><em>\u00a0for software.)<\/em><\/p><p>4 \u2013 Have any changes related to components\/parts \/ materials affected dimensional or performance specifications?<\/p><p>5 \u2013 Are you using a risk-based approach to evaluation of modifications?<\/p><p>6 \u2013 Have you documented your decision making?<\/p><h3>\u00a0<\/h3><h3>Software Activities That Are Likely\u00a0<em>Not<\/em>\u00a0Considered Remanufacturing<\/h3><p>Section VII of the guidance also talks about software-related changes and provides insights into what should be considered servicing activities, such as:<\/p><ul><li>Activities performed on behalf of, or otherwise explicitly authorized by, the OEM that return the legally marketed device to its performance and safety specifications, and intended use<\/li><li>Running software-based hardware diagnostics, accessing diagnostic and repair information, or implementing OEM-provided updates and upgrades (note that the OEM updates and upgrades should not significantly change the devices intended use)<\/li><li>Installation updates for viruses, malware, and other cybersecurity-related issues, or installing cybersecurity updates that are authorized by the OEM<\/li><li>Reinstalling OEM software to restore original performance and safety specifications or reverting software to a previous configuration<\/li><li>Turning on or off connectivity features (for example, wi-fi and Bluetooth connections) consistent with OEM intended use<\/li><li>Performing data backup and recovery operations, collecting system logs, assessing software inventory, or managing user accounts<\/li><\/ul><h3>\u00a0<\/h3><h3>Examples of Remanufacturing vs. Servicing and Documentation Requirements<\/h3><p>Perhaps the most useful section of the guidance is to be found in Appendix A. Here you will find 12 real-life examples illustrating the fine line between remanufacturing and servicing. Starting on page 31, you&#8217;ll also find some examples related to software. Finally, Appendix B contains advice on how you could document your evaluations.<\/p><p>It&#8217;s important to note that this is a draft FDA guidance and subject to change, but it reflects the current FDA thinking at the time of publication.<\/p><h3>\u00a0<\/h3><h3>Want to Learn More?<\/h3><p>Oriel STAT A MATRIX provides a variety of on-site and virtual training courses for medical device manufacturers, including\u00a0<a href=\"https:\/\/www.orielstat.com\/courses\/implementing-design-control-requirements-and-best-practices\" target=\"_blank\" rel=\"noopener noreferrer\">Design Control Training for Medical Devices<\/a>\u00a0and\u00a0<a href=\"https:\/\/www.orielstat.com\/courses\/FDA-QSR-training-21cfr820\" target=\"_blank\" rel=\"noopener noreferrer\">QMS Training for Medical Devices<\/a>. 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Servicing and Remanufacturing Many medical devices eventually require preventative maintenance or repairs, and this vital service can be performed by a manufacturer, health institution, independent servicing organization (ISO), or third-party service company. In a 2018 report, FDA noted that their analysis of comments, complaints, and adverse events revealed that [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1223,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[28],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.7 (Yoast SEO v21.7) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/www.orielstat.com\/blog\/fda-servicing-vs-remanufacturing\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"How FDA Distinguishes Between Medical Device Servicing and Remanufacturing Many medical devices eventually require preventative maintenance or repairs, and this vital service can be performed by a manufacturer, health institution, independent servicing organization (ISO), or third-party service company. 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