{"id":6794,"date":"2026-05-28T12:46:30","date_gmt":"2026-05-28T07:16:30","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=6794"},"modified":"2026-05-28T16:45:42","modified_gmt":"2026-05-28T11:15:42","slug":"us-fda-establishment-registration-and-listing","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/dz-en\/us-fda-establishment-registration-and-listing\/","title":{"rendered":"US FDA Medical Devices Establishment Registration and Device Listing"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6794\" class=\"elementor elementor-6794\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1cffd385 e-flex e-con-boxed e-con e-parent\" data-id=\"1cffd385\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-12d614ef elementor-widget elementor-widget-heading\" data-id=\"12d614ef\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">US FDA Medical Devices Establishment Registration and Device Listing<\/h1>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-20ceab3a e-flex e-con-boxed e-con e-parent\" data-id=\"20ceab3a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-78a3eca1 e-con-full e-flex e-con e-child\" data-id=\"78a3eca1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-71c74155 elementor-widget elementor-widget-heading\" data-id=\"71c74155\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What is Establishment Registration?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6334fe9d elementor-widget elementor-widget-text-editor\" data-id=\"6334fe9d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Every medical device manufacturer and distributor is required to register their organization with the FDA before selling their devices. Registration must be completed electronically through the FDA Unified Registration and Listing System (FURLS system), and approval from the FDA is necessary for operations to commence.<\/span><\/p><p><span style=\"font-weight: 400;\">Annual verification of registration details is mandatory, with a flexible timeframe offered by the FDA\u2014verification can be conducted anytime between October 1st and December 31st each year. The FDA levies registration fees, which are subject to periodic revisions and are a significant aspect of compliance for these establishments.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">For <\/span><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/fda-510k\/\"><span style=\"font-weight: 400;\">medical device FDA registration.<\/span><\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-467a37b8 e-con-full e-flex e-con e-child\" data-id=\"467a37b8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-7dc6d355 e-con-full e-flex e-con e-child\" data-id=\"7dc6d355\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-692daf33 elementor-widget elementor-widget-heading\" data-id=\"692daf33\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Regulatory Excellence for Global Medical Device Markets\n<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-788d2c1b elementor-widget elementor-widget-wpforms\" data-id=\"788d2c1b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wpforms-container wpforms-container-full wpforms-render-modern\" id=\"wpforms-6203\"><form id=\"wpforms-form-6203\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"6203\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/dz-en\/wp-json\/wp\/v2\/posts\/6794\" data-token=\"ec74508000ccae4945515a950d3da251\" data-token-time=\"1780154917\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div id=\"wpforms-error-noscript\" style=\"display: none;\">Please enable JavaScript in your browser to complete this form.<\/div><div class=\"wpforms-field-container\"><div id=\"wpforms-6203-field_1-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"1\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_1\" aria-hidden=\"false\">Name <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"text\" id=\"wpforms-6203-field_1\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][1]\" placeholder=\"Name*\" aria-errormessage=\"wpforms-6203-field_1-error\" required><\/div><div id=\"wpforms-6203-field_2-container\" class=\"wpforms-field wpforms-field-email\" data-field-id=\"2\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_2\" aria-hidden=\"false\">Email <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"email\" id=\"wpforms-6203-field_2\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][2]\" placeholder=\"Email*\" spellcheck=\"false\" aria-errormessage=\"wpforms-6203-field_2-error\" required><\/div>\t\t<div id=\"wpforms-6203-field_5-container\"\n\t\t\tclass=\"wpforms-field wpforms-field-text\"\n\t\t\tdata-field-type=\"text\"\n\t\t\tdata-field-id=\"5\"\n\t\t\t>\n\t\t\t<label class=\"wpforms-field-label\" for=\"wpforms-6203-field_5\" >Text Name Phone<\/label>\n\t\t\t<input type=\"text\" id=\"wpforms-6203-field_5\" class=\"wpforms-field-medium\" name=\"wpforms[fields][5]\" >\n\t\t<\/div>\n\t\t<div id=\"wpforms-6203-field_3-container\" class=\"wpforms-field wpforms-field-phone\" data-field-id=\"3\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_3\" aria-hidden=\"false\">Phone <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"tel\" id=\"wpforms-6203-field_3\" class=\"wpforms-field-large wpforms-field-required wpforms-smart-phone-field\" data-rule-smart-phone-field=\"true\" name=\"wpforms[fields][3]\" placeholder=\"Phone*\" aria-label=\"Phone\" aria-errormessage=\"wpforms-6203-field_3-error\" required><\/div><div id=\"wpforms-6203-field_4-container\" class=\"wpforms-field wpforms-field-textarea\" data-field-id=\"4\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_4\" aria-hidden=\"false\">Paragraph Text <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><textarea id=\"wpforms-6203-field_4\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][4]\" placeholder=\"Message\" aria-errormessage=\"wpforms-6203-field_4-error\" required><\/textarea><\/div><script>\n\t\t\t\t( function() {\n\t\t\t\t\tconst style = document.createElement( 'style' );\n\t\t\t\t\tstyle.appendChild( document.createTextNode( '#wpforms-6203-field_5-container { position: absolute !important; overflow: hidden !important; display: inline !important; height: 1px !important; width: 1px !important; z-index: -1000 !important; padding: 0 !important; } #wpforms-6203-field_5-container input { visibility: hidden; } #wpforms-conversational-form-page #wpforms-6203-field_5-container label { counter-increment: none; }' ) );\n\t\t\t\t\tdocument.head.appendChild( style );\n\t\t\t\t\tdocument.currentScript?.remove();\n\t\t\t\t} )();\n\t\t\t<\/script><\/div><!-- .wpforms-field-container --><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"6203\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/posts\/6794\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-6203\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Submit\" aria-live=\"assertive\" value=\"wpforms-submit\">Submit<\/button><img decoding=\"async\" src=\"https:\/\/operonstrategist.com\/wp-content\/plugins\/wpforms\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1ade2e57 e-flex e-con-boxed e-con e-parent\" data-id=\"1ade2e57\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2a57e82a elementor-widget elementor-widget-heading\" data-id=\"2a57e82a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Medical Device Listing\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-16d5ef43 elementor-widget elementor-widget-text-editor\" data-id=\"16d5ef43\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">As part of the medical device listing mandate, organizations must furnish information about the devices they manufacture. This includes providing a premarket submission number, such as 510(k), PMA (Premarket Approval), HDE (Humanitarian Device Exemption), etc., to the FDA if the device necessitates premarket procedures.\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ec0af53 elementor-widget elementor-widget-heading\" data-id=\"ec0af53\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Who Needs to Register With the FDA?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5a656fa elementor-widget elementor-widget-text-editor\" data-id=\"5a656fa\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">As a general rule, if you manufacture all or part of a medical device sold in the US, or perform processing (e.g., sterilization) on the device, you must register.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Except for Initial Importer, FDA also requires registered establishments to list the devices. An initial importer who is responsible for furthering the marketing of a device entering the US from a foreign manufacturer to the final distributor for sale of the device to the ultimate consumer or user must register their establishment but is not required to list the devices.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-40f7c3c elementor-widget elementor-widget-heading\" data-id=\"40f7c3c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What Are the Steps Involved in the Medical Device Establishment Registration Process?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1f46ad8 elementor-widget elementor-widget-text-editor\" data-id=\"1f46ad8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ol><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Create\/log in to the Facility User Fee Account with the US FDA\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Verify\/update Company Details and Generate the Payment Identification Number (PIN)\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Pay the 2024 Annual Registration User Fee Of $7,653 Electronically Through the Device Facility User Fee (DFUF) Website.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Registration and Listing Data is Entered Via the US FDA\u2019s Unified Registration and Listing (FURLS)\/the Device Registration and Listing Module (DRLM).\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">After the Registration Process is Complete, the US FDA Assigns an FDA Establishment Identifier (FEI) and Issues a Certificate Via the FDA Listing Inc.\u00a0<\/span><\/li><\/ol><p><span style=\"font-weight: 400;\">Also, read about <\/span><a href=\"https:\/\/operonstrategist.com\/fda-estar-submission-template\/\"><span style=\"font-weight: 400;\">A Guide to FDA eSTAR Submission Template<\/span><\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3e5f482 elementor-widget elementor-widget-heading\" data-id=\"3e5f482\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">How Operon Strategist Will Help You?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f8f7c33 elementor-widget elementor-widget-text-editor\" data-id=\"f8f7c33\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Partnering with Operon Strategist can significantly streamline the intricate process of US FDA establishment registration for medical devices. Our expertise in developing regulatory strategies, ensuring documentation compliance, navigating <\/span><a href=\"https:\/\/operonstrategist.com\/services\/turnkey-project\/quality-management-system\/\"><span style=\"font-weight: 400;\">quality management systems<\/span><\/a><span style=\"font-weight: 400;\">, facilitating communication with regulatory authorities, and supporting companies through audits and post-market compliance fosters a smoother path to successful registration. By leveraging our specialized guidance, companies can confidently navigate the complex regulatory landscape, ensuring adherence to FDA standards and expediting the approval process for their medical devices.\u00a0<\/span><\/p><p><a href=\"https:\/\/operonstrategist.com\/contact-us\/\"><span style=\"font-weight: 400;\">Contact us for more information<\/span><\/a>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>What is Establishment Registration? Every medical device manufacturer and distributor is required to register their organization with the FDA before selling their devices. Registration must be completed electronically through the FDA Unified Registration and Listing System (FURLS system), and approval from the FDA is necessary for operations to commence. Annual verification of registration details is [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":6805,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[22],"tags":[],"class_list":["post-6794","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-us-fda"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/posts\/6794","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/comments?post=6794"}],"version-history":[{"count":0,"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/posts\/6794\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/media\/6805"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/media?parent=6794"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/categories?post=6794"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/dz-en\/wp-json\/wp\/v2\/tags?post=6794"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}