{"id":7729,"date":"2023-09-10T21:30:17","date_gmt":"2023-09-10T21:30:17","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=7729"},"modified":"2024-01-10T22:26:56","modified_gmt":"2024-01-10T22:26:56","slug":"fda-abbreviated-510k-safety-performance-pathway","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/fda-abbreviated-510k-safety-performance-pathway\/","title":{"rendered":"FDA 510(k) Safety and Performance-Based Pathway Simplifies the Clearance Process for Well-Known Devices. Here&#8217;s How It Works."},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"7729\" class=\"elementor elementor-7729\" 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\/2023\/09\/10\/\">\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\tSeptember 10, 2023\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\">FDA 510(k) Safety and Performance-Based Pathway Simplifies the Clearance Process for Well-Known Devices. Here's How It Works.<\/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=\"2641\" height=\"1758\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Safety-and-Performance-Based-Pathway-Simplifies.jpg\" class=\"attachment-full size-full wp-image-1344\" alt=\"Safety and Performance-Based Pathway Simplifies\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Safety-and-Performance-Based-Pathway-Simplifies.jpg 2641w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Safety-and-Performance-Based-Pathway-Simplifies-300x200.jpg 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Safety-and-Performance-Based-Pathway-Simplifies-768x511.jpg 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Safety-and-Performance-Based-Pathway-Simplifies-1024x682.jpg 1024w\" sizes=\"(max-width: 2641px) 100vw, 2641px\" \/>\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>Each year, FDA clears thousands of medical devices via the 510(k) process. An overwhelming majority of those devices (80%+) go through the Traditional 510(k) process. Less than 2% go through the alluring Abbreviated 510(k) process. Why? Well, frankly there is very little that is abbreviated about that process, as it still requires the submitter to demonstrate substantial equivalence to a suitable predicate device.<\/p><p><strong>The FDA has finally done something to provide relief from this requirement it released a\u00a0<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/safety-and-performance-based-pathway\" target=\"_blank\" rel=\"noopener\">guidance<\/a> that supports the agency\u2019s regulatory mandate to offer the least burdensome approach to manufacturers.<\/strong><\/p><p>FDA finally recognized that the burden associated with preparing (manufacturer) and reviewing (internal FDA) predicate comparisons on devices\u00a0<u>that have been on the market for decades, have established performance standards,<\/u>\u00a0and\u00a0<u>are well-understood\u00a0<\/u>outweighed any potential contributions to patient or user safety.<\/p><p>The Safety and Performance-Based Pathway is an expansion of the Abbreviated 510(k) process. It is important to note that it will not replace the Abbreviated 510(k) pathway but will instead run in parallel. The Abbreviated 510(k) relies on the use of FDA guidance documents, special controls, and FDA-recognized consensus standards (examples: IEC 60601-1, ISO 14971:2007) and requires comparison to an appropriate predicate device(s).<\/p><h3>\u00a0<\/h3><h3>How This Expanded Concept of the Abbreviated 510(k) Program Works<\/h3><p>In a nutshell, the new pathway essentially allows for very well-established devices to demonstrate their safety and effectiveness without requiring the submitter to perform direct comparison testing to a predicate device. Heres what FDA has to say about it:<\/p><p>If a legally marketed device performs at certain levels relevant to its safety and effectiveness, and a new device meets those levels of performance for the same characteristics, FDA could find that the new device is as safe and effective as the legally marketed device. Instead of reviewing data from direct comparison testing between the two devices, FDA could support a finding of substantial equivalence based on data showing the new device meets the level of performance of appropriate predicate device(s).\u201d<\/p><h3>\u00a0<\/h3><h3>Is This a Shortcut?<\/h3><p>Sort of. Manufacturers will still need to meet all the requirements outlined in FDA published guidance documents. You will still need to follow consensus standards and perform appropriate performance testing. However, regulatory specialists utilizing this pathway will no longer have to require their companies to procure and conduct direct comparison testing to a competitive predicate device. That saves time and money.<\/p><p>The format of the submission will be the same as a typical 510(k) and all sections must be completed. In addition, FDA expects you to submit a Declaration of Conformity plus a summary of the data, testing protocols, and\/or other underlying data, as appropriate, to prove that your device meets appropriate tests outlined in guidance documents.<\/p><h3>\u00a0<\/h3><h3>Devices Appropriate for This Pathway<\/h3><p>The agency has published a list of devices that are appropriate for this pathway <a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-notification-510k\/safety-and-performance-based-pathway\" target=\"_blank\" rel=\"noopener\">here<\/a>. Companies lucky enough to make products that qualify for this pathway should find the path to clearance to be well defined and easier to follow. FDA has also said they will change this list over time, even removing some devices if needed. However, once a device is cleared via this pathway, the FDA has stated that the device may retain its 510(k) clearance unless there is a safety concern.<\/p><h3>\u00a0<\/h3><h3>Let Oriel STAT A MATRIX Assist with 510(k) Training or Preparation<\/h3><p>If you&#8217;re ready to take the next step and want a deeper look inside the 510(k) preparation process, consider our <a href=\"https:\/\/www.orielstat.com\/courses\/FDA-510k-CE-Mark-medial-device-training\" target=\"_blank\" rel=\"noopener noreferrer\">training<\/a> class. Our team of FDA consultants can also assist you in all aspects of <a href=\"https:\/\/www.orielstat.com\/practice\/FDA-510k-submissions-consulting\" target=\"_blank\" rel=\"noopener noreferrer\">510(k) strategy or preparation<\/a>. Let us know how we can help you!<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a3400fd elementor-widget elementor-widget-shortcode\" data-id=\"a3400fd\" data-element_type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-shortcode\"><div class=\"container\">\n    <div class=\"col-lg-12 col-md-12\">\n        <h5 class=\"elementor-heading-title elementor-size-default\">Our team is here to help. <a href=\"javascript:void(0);\" rel=\"nofollow\" noindex=\"noindex\">Contact us online<\/a><\/h5>\n        <h5 class=\"elementor-heading-title elementor-size-default\">or<\/h5>\n        <h6 class=\"elementor-heading-title elementor-size-default\">Get answers right now. Call<\/h6>\n    <\/div>\n    <div id=\"Bottom_icons1_DivOfficePhone\" class=\"row new_update_add\">\n<div class=\"col-lg-6 col-md-12 borderbottom\">\n <div class=\"block-text1\">\n     <img decoding=\"async\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/11\/us-flag.jpg\">\n     <p>\n         <b>US Office<\/b>Washington DC<\/p>\n <\/div>\n <p>\n     <a href=\"tel:1.800.472.6477\">1.800.472.6477<\/a><\/p>\n<\/div>\n<div class=\"col-lg-6 col-md-12\">\n <div class=\"block-text1\">\n     <p>\n         <b>EU Office<\/b>Cork, Ireland<\/p>\n     <img decoding=\"async\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/11\/eu-flag.jpg\" class=\"img-right-sec\">\n <\/div>\n <p>\n     <a href=\"tel:+353 21 212 8530\">+353 21 212 8530<\/a><\/p>\n<\/div>\n<\/div>\n<\/div><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-d2b128c\" data-id=\"d2b128c\" 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<div class=\"elementor-element elementor-element-3de1869 elementor-widget elementor-widget-sidebar\" data-id=\"3de1869\" data-element_type=\"widget\" data-widget_type=\"sidebar.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<section id=\"search-2\" class=\"widget widget_search\"><form role=\"search\" method=\"get\" class=\"search-form\" action=\"https:\/\/www.orielstat.com\/blog\/\">\n\t\t\t\t<label>\n\t\t\t\t\t<span class=\"screen-reader-text\">Search for:<\/span>\n\t\t\t\t\t<input type=\"search\" class=\"search-field\" placeholder=\"Search &hellip;\" value=\"\" name=\"s\" \/>\n\t\t\t\t<\/label>\n\t\t\t\t<input type=\"submit\" class=\"search-submit\" value=\"Search\" \/>\n\t\t\t<\/form><\/section><section id=\"block-2\" class=\"widget widget_block\">\n<figure class=\"wp-block-image size-large\"><a href=\"#mailmunch-pop-545876\"><img decoding=\"async\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2017\/06\/Blog-subscribe.jpg\" alt=\"\"><\/a><\/figure><\/section><section id=\"categories-3\" class=\"widget widget_categories\"><h2 class=\"widget-title\">Search by Topic<\/h2>\n\t\t\t<ul>\n\t\t\t\t\t<li class=\"cat-item cat-item-12\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/all-medical-device-ra-qa\/\">All Category<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-74\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/ai\/\">Artificial Intelligence (AI)<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-64\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/auditing\/\">Auditing<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-71\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/capa\/\">CAPA<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-20\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/capa-for-medical-devicecompliance\/\">CAPA and Root Cause Analysis<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-27\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/clinical-evaluation-reports\/\">Clinical Evaluation Reports<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-59\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/combination-products\/\">Combination Products<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-23\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/complaint-handling-postmarket-surveillance\/\">Complaint Handling and PMS<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-33\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/design-control\/\">Design Control<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-34\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/in-vitro-diagnostics-ivdr\/\">EU IVDR (2017\/746)<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-16\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/eu-medical-device-regulation\/\">EU MDR (2017\/745)<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-14\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/us-fda-qsr\/\">FDA 21 CFR Part 820<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-21\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/510k-submissions\/\">FDA 510(k) Submissions<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-69\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/fda-eua\/\">FDA EUA<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-4\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/iso-134852016\/\">ISO 13485 QMS Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-30\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/risk-management-iso14971\/\">ISO 14971 Risk Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-40\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/laboratory-developed-tests-ldt\/\">Lab Developed Tests<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-66\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/labeling\/\">Labeling<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-18\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/mdsap\/\">MDSAP<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-58\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/pharmaceutical\/\">Pharmaceuticals<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-28\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qms-auditing\/\">QMS Auditing<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-72\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qmsr\/\">QMSR<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-73\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/regulatory-compliance\/\">Regulatory Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-65\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software\/\">Software<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-63\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software-cybersecurity\/\">Software and Cybersecurity<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-32\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/supplier-management\/\">Supplier Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-67\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/training\/\">Training<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-1\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/medical-device-ra-qa\/\">Uncategorized<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-35\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/validation\/\">Validation<\/a>\n<\/li>\n\t\t\t<\/ul>\n\n\t\t\t<\/section>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>FDA 510(k) Safety and Performance-Based Pathway Simplifies the Clearance Process for Well-Known Devices. Here&#8217;s How It Works. Each year, FDA clears thousands of medical devices via the 510(k) process. An overwhelming majority of those devices (80%+) go through the Traditional 510(k) process. Less than 2% go through the alluring Abbreviated 510(k) process. Why? Well, frankly [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1344,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[4,18],"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=\"description\" content=\"Learn more about the FDA safety and performance-based pathway and which devices can use this enticing new option.\" \/>\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-abbreviated-510k-safety-performance-pathway\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"Learn more about the FDA safety and performance-based pathway and which devices can use this enticing new option.\" \/>\r\n<meta property=\"og:url\" content=\"https:\/\/www.orielstat.com\/blog\/fda-abbreviated-510k-safety-performance-pathway\/\" \/>\r\n<meta property=\"og:site_name\" content=\"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog\" \/>\r\n<meta property=\"article:published_time\" content=\"2023-09-10T21:30:17+00:00\" \/>\r\n<meta property=\"article:modified_time\" content=\"2024-01-10T22:26:56+00:00\" \/>\r\n<meta property=\"og:image\" content=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Safety-and-Performance-Based-Pathway-Simplifies.jpg\" \/>\r\n\t<meta property=\"og:image:width\" content=\"2641\" \/>\r\n\t<meta property=\"og:image:height\" content=\"1758\" \/>\r\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\r\n<meta name=\"author\" content=\"usr192162\" \/>\r\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\r\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"usr192162\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\r\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog","description":"Learn more about the FDA safety and performance-based pathway and which devices can use this enticing new option.","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":"https:\/\/www.orielstat.com\/blog\/fda-abbreviated-510k-safety-performance-pathway\/","og_locale":"en_US","og_type":"article","og_description":"Learn more about the FDA safety and performance-based pathway and which devices can use this enticing new option.","og_url":"https:\/\/www.orielstat.com\/blog\/fda-abbreviated-510k-safety-performance-pathway\/","og_site_name":"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog","article_published_time":"2023-09-10T21:30:17+00:00","article_modified_time":"2024-01-10T22:26:56+00:00","og_image":[{"width":2641,"height":1758,"url":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Safety-and-Performance-Based-Pathway-Simplifies.jpg","type":"image\/jpeg"}],"author":"usr192162","twitter_card":"summary_large_image","twitter_misc":{"Written by":"usr192162","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.orielstat.com\/blog\/fda-abbreviated-510k-safety-performance-pathway\/#article","isPartOf":{"@id":"https:\/\/www.orielstat.com\/blog\/fda-abbreviated-510k-safety-performance-pathway\/"},"author":{"name":"usr192162","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/a775f07c9602a3521143e80692594553"},"headline":"FDA 510(k) Safety and Performance-Based Pathway Simplifies the Clearance Process for Well-Known Devices. Here&#8217;s How It Works.","datePublished":"2023-09-10T21:30:17+00:00","dateModified":"2024-01-10T22:26:56+00:00","mainEntityOfPage":{"@id":"https:\/\/www.orielstat.com\/blog\/fda-abbreviated-510k-safety-performance-pathway\/"},"wordCount":652,"publisher":{"@id":"https:\/\/www.orielstat.com\/blog\/#organization"},"articleSection":["ISO 13485 QMS Compliance","MDSAP"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.orielstat.com\/blog\/fda-abbreviated-510k-safety-performance-pathway\/","url":"https:\/\/www.orielstat.com\/blog\/fda-abbreviated-510k-safety-performance-pathway\/","name":"","isPartOf":{"@id":"https:\/\/www.orielstat.com\/blog\/#website"},"datePublished":"2023-09-10T21:30:17+00:00","dateModified":"2024-01-10T22:26:56+00:00","description":"Learn more about the FDA safety and performance-based pathway and which devices can use this enticing new option.","inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.orielstat.com\/blog\/fda-abbreviated-510k-safety-performance-pathway\/"]}]},{"@type":"WebSite","@id":"https:\/\/www.orielstat.com\/blog\/#website","url":"https:\/\/www.orielstat.com\/blog\/","name":"Oriel STAT A MATRIX Blog","description":"","publisher":{"@id":"https:\/\/www.orielstat.com\/blog\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.orielstat.com\/blog\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/www.orielstat.com\/blog\/#organization","name":"Oriel STAT A MATRIX Blog","url":"https:\/\/www.orielstat.com\/blog\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/logo\/image\/","url":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/OSAM-Eliquent-logo-color.png","contentUrl":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/OSAM-Eliquent-logo-color.png","width":1458,"height":1042,"caption":"Oriel STAT A MATRIX Blog"},"image":{"@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/a775f07c9602a3521143e80692594553","name":"usr192162","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/1412cb81dc66fbc000fb222b1ea52700?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/1412cb81dc66fbc000fb222b1ea52700?s=96&d=mm&r=g","caption":"usr192162"},"url":"https:\/\/www.orielstat.com\/blog\/author\/usr192162\/"}]}},"_links":{"self":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/7729"}],"collection":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/comments?post=7729"}],"version-history":[{"count":9,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/7729\/revisions"}],"predecessor-version":[{"id":7751,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/7729\/revisions\/7751"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/media\/1344"}],"wp:attachment":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/media?parent=7729"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/categories?post=7729"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/tags?post=7729"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}