{"id":8239,"date":"2024-01-12T19:17:25","date_gmt":"2024-01-12T19:17:25","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=8239"},"modified":"2024-01-12T19:26:11","modified_gmt":"2024-01-12T19:26:11","slug":"medical-device-eua-510k","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/medical-device-eua-510k\/","title":{"rendered":"How to Transition Your Medical Device EUA to an FDA 510(k)"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8239\" class=\"elementor elementor-8239\" 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\/12\/\">\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 12, 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 to Transition Your Medical Device EUA to an FDA 510(k)<\/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=\"2560\" height=\"1461\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/08\/ventilators-row-scaled.jpeg\" class=\"attachment-full size-full wp-image-6372\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/08\/ventilators-row-scaled.jpeg 2560w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/08\/ventilators-row-300x171.jpeg 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/08\/ventilators-row-1024x585.jpeg 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/08\/ventilators-row-768x438.jpeg 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/08\/ventilators-row-1536x877.jpeg 1536w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/08\/ventilators-row-2048x1169.jpeg 2048w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/08\/ventilators-row-500x285.jpeg 500w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/>\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>The COVID-19 public health emergency (PHE) declaration expired on May 11, 2023, which means termination of medical device Emergency Use Authorizations (EUAs) and pandemic-era policy enforcement is imminent. Manufacturers who previously secured an EUA need to take action now, especially if you intend to keep your products on the market.<\/p><p>FDA is requiring a marketing submission and full compliance with most regulations, including 21 CFR Part 820 (quality system regulation). Companies navigating medical device requirements for the first time may find themselves under pressure to comply by the proposed deadlines.<\/p><p>In this article, we will focus on steps you should take to\u00a0<em>continue<\/em>\u00a0marketing your device after your EUA expires, including timelines for complying with FDA regulations, navigating the FDA 510(k) process, and considerations for specific device types. Let\u2019s dig in.<\/p><h3>\u00a0<\/h3><h3>FDA Guidance on Medical Device and IVD EUA Transition Plans<\/h3><p>In March 2023, FDA finalized two guidances that clarify next steps for manufacturers with medical devices or\u00a0<em>in vitro<\/em>\u00a0diagnostics (IVDs)\u00a0on the US market under EUA or the pandemic enforcement policies:<\/p><ul><li><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/transition-plan-medical-devices-issued-emergency-use-authorizations-euas-during-coronavirus-disease\" target=\"_blank\" rel=\"nofollow noopener\">Transition Plan For Medical Devices Issued Emergency Use Authorizations (EUAs) Related To Coronavirus Disease 2019 (COVID-19)<\/a><\/li><li><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/transition-plan-medical-devices-fall-within-enforcement-policies-issued-during-coronavirus-disease\" target=\"_blank\" rel=\"nofollow noopener\">Transition Plan For Medical Devices That Fall Within Enforcement Policies Issued During The Coronavirus Disease 2019 (COVID-19) Public Health Emergency<\/a><\/li><\/ul><p>Both documents are must-reads for understanding what happens when the pandemic-era authorization for a device is terminated. Here are key takeaways from the final guidances:<\/p><ul><li>FDA plans a phased transition away from the pandemic enforcement. The first phase began with the PHE expiration announcement on May 11, 2023. The transition period spans 180 days.<\/li><li>Health and Human Services (HHS) will announce plans to expire an EUA in the Federal Register 180 days before its termination date. This announcement will start the clock for manufacturers of relevant devices to comply with federal regulations. However, manufacturers with EUAs are urged to begin preparing their submissions as soon as possible.<\/li><li>If you intend to distribute devices after the EUA expiration date \/ transition period, your marketing submission must be accepted by FDA for substantive review\u00a0<em>before<\/em>\u00a0the EUA expiration date and \/ or the end of Phase 2.<\/li><\/ul><h3>\u00a0<\/h3><h3>Transition Timeline for Complying With FDA Requirements<\/h3><p>Final enforcement policy transition guidance recommends that manufacturers consider the following phases to achieve compliance:<\/p><ul><li><strong>Phase 1:<\/strong>\u00a0The first phase began on May 11, 2023, when the PHE expired. At this point, FDA expects manufacturers to comply with 21 CFR Part 803 on medical device adverse reporting if they are not already doing so.<\/li><li><strong>Phase 2:<\/strong>\u00a0The second phase began on August 9, 2023. FDA expects manufacturers to be in compliance with 21 CFR Part 806 and Subparts B, C, and D of 21 CFR Part 807 if they are planning to continue distributing devices after Phase 2.<\/li><li><strong>Phase 3:<\/strong>\u00a0Finally, the third phase begins November 7, 2023, 180 days after the PHE expiration. Manufacturers are expected to be in full compliance with FDA requirements \u2013 including\u00a0quality system regulation (QSR), unique device identification (UDI),\u00a0and labeling \u2013 if they intend to continue marketing their device.<\/li><\/ul><p>This transition plan was designed to minimize device supply chain disruptions and preserve FDA\u2019s capacity to review marketing submissions in a timely manner. However, the typical 510(k) usually takes longer than 180 days to prepare. If your device requires a different submission type, such as a premarket approval or De Novo application, it may take even longer, especially if you require clinical trials. In this case, you should engage with FDA and begin compiling your submission as soon as possible.<\/p><p>A final action or decision from FDA is not required to continue distribution beyond the EUA termination. FDA won\u2019t object to continued distribution of devices (in most cases) as long as your marketing submission has been accepted for review. However, you must stop distributing devices immediately if you receive a negative decision from FDA.<\/p><h3>\u00a0<\/h3><h3>510(k) Process for Medical Devices With EUAs<\/h3><p>If you\u2019ve decided to continue selling your product after the EUA is terminated, you will need to move forward with FDA\u2019s regulatory process, which, for most devices, means submitting an FDA 510(k). The 510(k) is a dossier of information about your device that proves it is substantially equivalent to another device already cleared by FDA, called a predicate. The predicate defines your device\u2019s risk classification (Class I, II, or III) and its three-letter product code. You can search for already-cleared devices on the\u00a0<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpmn\/pmn.cfm\" target=\"_blank\" rel=\"nofollow noopener\">FDA 510(k) database.<\/a><\/p><p>If your device is very high risk (Class III) or you can\u2019t find a suitable predicate, you may need to follow a different regulatory pathway:<\/p><ul><li>Class III devices may require premarket approval (PMA), which includes a more comprehensive submission dossier than the 510(k) and more rigorous regulatory obligations.<\/li><li>Novel devices with no predicate may also require PMA, or you may be eligible for FDA\u2019s De Novo.<\/li><\/ul><p>To determine the best path forward, file an application for FDA to evaluate data on your device and determine its classification, called a\u00a0<em>513(g) Request for Information<\/em>.\u00a0<a href=\"https:\/\/www.orielstat.com\/contact-us\" target=\"_blank\" rel=\"nofollow noopener\">Or just ask us!<\/a><\/p><h3>\u00a0<\/h3><h3>Additional FDA Submission Items for EUA Devices<\/h3><p>In addition to the usual 510(k) requirements, FDA requests two additional items with marketing submissions for devices transitioning from an EUA:<\/p><ul><li><strong>Cover letter indicating transition from EUA.<\/strong>\u00a0The cover letter should indicate the device is currently under an EUA \/ enforcement policy. It should also include the EUA request number and submission number(s) for related premarket submissions.<\/li><li><strong>Transition implementation plan.<\/strong>\u00a0This document should include an estimated number of devices in distribution, as well as outline your plans for distributed devices in the event of a positive\u00a0<em>or<\/em>\u00a0negative decision from FDA. Refer to the guidance for a detailed explanation of what to include in the transition implementation plan.<\/li><\/ul><p>If you have never prepared an FDA submission \u2013 which is the case for many product manufacturers with EUAs \u2013 FDA\u2019s\u00a0<a href=\"https:\/\/www.orielstat.com\/consulting\/FDA-Pre-Submission-Q-Submission-consulting\" target=\"_blank\" rel=\"nofollow noopener\">Q-Submission\/Pre-Submission Program<\/a>\u00a0allows you to discuss your questions with FDA reviewers.<\/p><p>FDA is making exceptions for certain life-saving and life-supporting devices = such as ventilators, certain anesthesia machines, portable oxygen generators, and tubing connectors = that will require a longer time frame for approval due to their high-risk profile and \/ or the potential negative impact of low supply. If you manufacture these products, you should send a Notice of Intent to the Center for Diseases and Radiological Health (CDRH) as soon as possible if you have not already done so. The notice should indicate if you intend to submit a marketing submission or outline your plans to discontinue distribution of the device by the EUA termination date. Refer to the guidance for a more detailed explanation of what to include in your Notice of Intent.<\/p><h3>\u00a0<\/h3><h3>What EUA Device Companies Need to Know About QMS Compliance Under US FDA<\/h3><p>Implementing a quality management system (QMS) that complies with FDA\u2019s QSR 21 CFR Part 820 will be a major undertaking for manufacturers that have no previous experience complying with FDA regulations. FDA\u2019s enforcement of QMS requirements involves a combination of premarket review [including documentation submitted with your 510(k) or PMA], facility inspections, postmarket surveillance, and corrective actions to ensure that manufacturers establish and maintain effective quality management systems.<\/p><p>However, FDA has indicated it will make QMS enforcement decisions on a case-by-case basis for EUA devices transitioning to standard compliance. To request a potential exemption or deferment, submit your QMS exemption request to the FDA within 90 days of your EUA termination announcement.<\/p><h3>\u00a0<\/h3><h3>Take the Next Step Toward FDA Compliance<\/h3><p>FDA clearance for Class I or II devices can take at least 12 to 18 months. If your device is high risk or has no predicate, plan on compliance taking much longer. With FDA\u2019s transition plan already in motion, many companies are rushing to get their submissions ready before the deadline. However, you don\u2019t have to do this alone. Oriel STAT A MATRIX can help you get into full compliance with\u00a0<a href=\"https:\/\/www.orielstat.com\/practice\/implementing-ISO-13485-FDA-quality-system\" target=\"_blank\" rel=\"nofollow noopener\">FDA QSR<\/a>,\u00a0<a href=\"https:\/\/www.orielstat.com\/courses\/FDA-QSR-training-21cfr820\" target=\"_blank\" rel=\"nofollow noopener\">train your team<\/a>, and get you ready to submit your\u00a0<a href=\"https:\/\/www.orielstat.com\/practice\/FDA-510k-submissions-consulting\" target=\"_blank\" rel=\"nofollow noopener\">510(k)<\/a>\u00a0or\u00a0<a href=\"https:\/\/www.orielstat.com\/practice\/FDA-Premarket-Approval-PMA-Application-Medical-Devices\" target=\"_blank\" rel=\"nofollow noopener\">PMA<\/a>\u00a0submission.<\/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. 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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>How to Transition Your Medical Device EUA to an FDA 510(k) The COVID-19 public health emergency (PHE) declaration expired on May 11, 2023, which means termination of medical device Emergency Use Authorizations (EUAs) and pandemic-era policy enforcement is imminent. Manufacturers who previously secured an EUA need to take action now, especially if you intend to [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":6372,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[69],"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\/medical-device-eua-510k\/\" \/>\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 to Transition Your Medical Device EUA to an FDA 510(k) The COVID-19 public health emergency (PHE) declaration expired on May 11, 2023, which means termination of medical device Emergency Use Authorizations (EUAs) and pandemic-era policy enforcement is imminent. Manufacturers who previously secured an EUA need to take action now, especially if you intend to [&hellip;]\" \/>\r\n<meta property=\"og:url\" content=\"https:\/\/www.orielstat.com\/blog\/medical-device-eua-510k\/\" \/>\r\n<meta property=\"og:site_name\" content=\"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog\" \/>\r\n<meta property=\"article:published_time\" content=\"2024-01-12T19:17:25+00:00\" \/>\r\n<meta property=\"article:modified_time\" content=\"2024-01-12T19:26:11+00:00\" \/>\r\n<meta property=\"og:image\" content=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/08\/ventilators-row-scaled.jpeg\" \/>\r\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\r\n\t<meta property=\"og:image:height\" content=\"1461\" \/>\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=\"7 minutes\" \/>\r\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog","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\/medical-device-eua-510k\/","og_locale":"en_US","og_type":"article","og_description":"How to Transition Your Medical Device EUA to an FDA 510(k) The COVID-19 public health emergency (PHE) declaration expired on May 11, 2023, which means termination of medical device Emergency Use Authorizations (EUAs) and pandemic-era policy enforcement is imminent. 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