{"id":6429,"date":"2026-05-18T17:59:16","date_gmt":"2026-05-18T12:29:16","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=6429"},"modified":"2026-05-18T17:59:16","modified_gmt":"2026-05-18T12:29:16","slug":"fda-estar-submission-template","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/sa-en\/fda-estar-submission-template\/","title":{"rendered":"A Guide to FDA eSTAR Submission Template"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6429\" class=\"elementor elementor-6429\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2eb5def7 e-flex e-con-boxed e-con e-parent\" data-id=\"2eb5def7\" 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-1f296f43 elementor-widget elementor-widget-heading\" data-id=\"1f296f43\" 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\">A Guide to FDA eSTAR Submission Template<\/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-420b6c39 e-flex e-con-boxed e-con e-parent\" data-id=\"420b6c39\" 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-6e86397b e-con-full e-flex e-con e-child\" data-id=\"6e86397b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5c57c690 elementor-widget elementor-widget-heading\" data-id=\"5c57c690\" 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 eSTAR?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-64594125 elementor-widget elementor-widget-text-editor\" data-id=\"64594125\" 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>Starting October 1, 2023, all 510(k) submissions, unless exempt, are required to be electronically filed through eSTAR. This electronic system is specifically tailored as an interactive PDF document for assembling a comprehensive pre-market submission of medical devices intended for <a href=\"https:\/\/operonstrategist.com\/elevateplus\/us-fda-510k-qsmr-registration\/\">FDA 510(k)<\/a> clearance within the United States. Additionally, eSTAR offers a resource for applicants to respond to FDA requests for supplementary information, enhancing the submission process. The primary goal behind eSTAR is to elevate the standard of submissions across diverse medical devices by ensuring submitters furnish thorough and top-notch data for the FDA\u2019s pre-market review.<\/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-6b637fc1 e-con-full e-flex e-con e-child\" data-id=\"6b637fc1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-714af171 e-con-full e-flex e-con e-child\" data-id=\"714af171\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7b0b1e83 elementor-widget elementor-widget-heading\" data-id=\"7b0b1e83\" 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\">Talk to our experts<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-65de7950 elementor-widget elementor-widget-wpforms\" data-id=\"65de7950\" 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=\"\/sa-en\/wp-json\/wp\/v2\/posts\/6429\" data-token=\"79a083f905526ffeff35543e9571c185\" data-token-time=\"1779268331\"><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\">\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\" >Name Phone Paragraph<\/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_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><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\/sa-en\/wp-json\/wp\/v2\/posts\/6429\"><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-1fd01a90 e-flex e-con-boxed e-con e-parent\" data-id=\"1fd01a90\" 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-7227807 elementor-widget elementor-widget-heading\" data-id=\"7227807\" 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\">Where Can I Access and Submit eSTAR for Pre-market Submission?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4fa3f60b elementor-widget elementor-widget-text-editor\" data-id=\"4fa3f60b\" 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;\">Accessing and utilizing eSTAR for a medical device submission involves several key steps:\u00a0\u00a0<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Download the eSTAR PDF Template: Obtain the eSTAR template from the FDA website, accessible under the eSTAR Program. Versions specific to medical devices and In Vitro Diagnostic devices are available for download.\u00a0\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Prepare the Submission: Utilize the downloaded eSTAR submission template, which provides a standardized format inclusive of prompts, questions, and guidance. This standardized structure aids applicants in furnishing precise and comprehensive information required for the submission.\u00a0\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Register for an Account: Access the CDRH Portal and register for an account. This registration is open to all individuals and facilitates the submission of CDRH eSTAR or eCopy pre-market submissions conveniently via an online platform.\u00a0\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Submit the Application: Starting from October 1, 2023, ensure that all 510(k) submissions, except those that are exempt, are electronically submitted exclusively through eSTAR.\u00a0<\/span><\/li><\/ul>\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<div class=\"elementor-element elementor-element-6374c49 e-flex e-con-boxed e-con e-parent\" data-id=\"6374c49\" 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-6eaaf17 elementor-widget elementor-widget-heading\" data-id=\"6eaaf17\" 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\">Guidance of eSTAR Submission Template<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2b0f704 elementor-widget elementor-widget-text-editor\" data-id=\"2b0f704\" 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;\">\u201cProviding Regulatory Submissions for Medical Devices in Electronic Format \u2013 Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act\u201d contains essential guidance regarding the development of templates for electronic submissions, which led to the creation of eSTAR submission template and could be used for creating proprietary templates. \u201cElectronic Submission Template for Medical Device 510(k) Submissions\u201d contains final FDA guidelines for electronic submissions, including exemptions for situations where users may not need to use eSTAR. Consulting these documents is an essential first step in determining whether and how users need to submit via eSTAR.\u00a0\u00a0<\/span><\/p><p><strong>Online:\u00a0<\/strong><\/p><p><span style=\"font-weight: 400;\">For CDRH, send eSTAR premarket submissions online through the CDRH Portal:\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Send and Track Medical Device Premarket Submissions Online: CDRH Portal\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">For CBER, send eSTAR premarket submissions online through the FDA\u2019s Electronic Submission Gateway (ESG) method. Instructions available at:\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Regulated Submissions in Electronic and Paper Format for CBER-Regulated Products\u00a0<\/span><\/p><p><strong>By Mail:\u00a0<\/strong><\/p><p><span style=\"font-weight: 400;\">eSTARs submitted by mail to CDRH\u2019s Document Control Center (DCC) should be sent to:\u00a0<\/span><\/p><p><a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">U.S. Food and Drug Administration <\/span><\/a><span style=\"font-weight: 400;\"><br \/><\/span><span style=\"font-weight: 400;\">Center for Devices and Radiological Health <\/span><span style=\"font-weight: 400;\"><br \/><\/span><span style=\"font-weight: 400;\">Document Control Center (DCC) \u2013 WO66-G609 <\/span><span style=\"font-weight: 400;\"><br \/><\/span><span style=\"font-weight: 400;\">10903 New Hampshire Avenue <\/span><span style=\"font-weight: 400;\"><br \/><\/span><span style=\"font-weight: 400;\">Silver Spring, MD 20993-0002\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">eSTARs submitted by mail to CBER\u2019s Document Control Center (DCC) should be sent to:\u00a0<\/span><\/p><p><strong>U.S. Food and Drug Administration <br \/><\/strong><span style=\"font-weight: 400;\">Center for Biologics Evaluation and Research <\/span><span style=\"font-weight: 400;\"><br \/><\/span><span style=\"font-weight: 400;\">Document Control Center <\/span><span style=\"font-weight: 400;\"><br \/><\/span><span style=\"font-weight: 400;\">10903 New Hampshire Avenue \u2013 WO71, G112 <\/span><span style=\"font-weight: 400;\"><br \/><\/span><span style=\"font-weight: 400;\">Silver Spring, MD 20993-0002<\/span><\/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<div class=\"elementor-element elementor-element-7a4edd8 e-flex e-con-boxed e-con e-parent\" data-id=\"7a4edd8\" 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-c838005 elementor-widget elementor-widget-heading\" data-id=\"c838005\" 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\">eSTAR Submission Template\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fd6b696 elementor-widget elementor-widget-text-editor\" data-id=\"fd6b696\" 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;\">Explore the FDA eSTAR submission template thoroughly to understand each section\u2019s information and format requirements. Fields in eSTAR become visible based on the choices you make, such as selecting submission types like Traditional, Abbreviated, or Special. By answering questions, additional fields tailored to your selection appear. Create a parallel template outside eSTAR to align and prepare the required information for a smoother submission process. This proactive approach ensures you gather and organize the necessary details efficiently. <\/span><\/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<div class=\"elementor-element elementor-element-7400614 e-flex e-con-boxed e-con e-parent\" data-id=\"7400614\" 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-51a704b elementor-widget elementor-widget-heading\" data-id=\"51a704b\" 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 The Review Timeline For eSTAR?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2f82a29 elementor-widget elementor-widget-text-editor\" data-id=\"2f82a29\" 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;\">The timeline for the various stages of the eSTAR submission process is outlined as follows:\u00a0\u00a0\u00a0<\/span><\/p><ol><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Refuse to Accept (RTA) Review: Completed within 15 days from the date of submission. During this phase, the FDA determines if the submission is complete and meets minimum requirements.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Substantive Review: Carried out within 60 days following the RTA review. This phase involves a thorough assessment of the submission\u2019s content and compliance with regulatory standards.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Decision Letter: Issued within 90 days after the substantive review. The decision letter communicates the FDA\u2019s decision regarding the clearance or approval status of the submission.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Additional Information (AI) Requests: If the FDA requests additional documents or information, the submitter has 180 days to provide the requested materials from the date of the request.<br \/><br \/><\/span><\/li><\/ol><p><span style=\"font-weight: 400;\">If an eSTAR submission is incomplete upon filing, the FDA will notify the submitter via email regarding the missing information. The submission will be put on hold for 180 days or until a replacement eSTAR containing all the required information is submitted to the FDA.\u00a0\u00a0\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Throughout the remainder of the 510(k) review process, the FDA follows its guidelines. Meanwhile, a De Novo classification request undergoes review as per 21 CFR p860, Subpart D, and aligns with the guidance provided by the FDA.<\/span><\/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<div class=\"elementor-element elementor-element-b6345bc e-flex e-con-boxed e-con e-parent\" data-id=\"b6345bc\" 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-6d4bbc5 elementor-widget elementor-widget-heading\" data-id=\"6d4bbc5\" 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\">Benefits of Using eSTAR for Medical Device Submissions:\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a01a487 elementor-widget elementor-widget-text-editor\" data-id=\"a01a487\" 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;\">The eSTAR program offers several advantages that significantly impact the medical device submission process:\u00a0\u00a0\u00a0<\/span><\/p><ol><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Improved Transparency and Consistency: By providing a standardized format and a guided process, eSTAR ensures transparency and consistency in submissions. This standardized approach leads to increased completeness, streamlining the pre-market review process by the FDA. Consequently, it facilitates timely access to safe, effective, and high-quality medical devices. <\/span><span style=\"font-weight: 400;\"><br \/><\/span><span style=\"font-weight: 400;\">\u00a0\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Enhanced Submission Quality: eSTAR dynamically generates relevant fields or sections based on initial responses, prompting submitters to provide comprehensive and high-quality data. This proactive approach significantly improves the quality of submissions, consequently enhancing the FDA\u2019s pre-market review process. <\/span><span style=\"font-weight: 400;\"><br \/><\/span><span style=\"font-weight: 400;\">\u00a0\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Streamlined Submission Process: Through an interactive PDF form, eSTAR simplifies the submission process, guiding applicants in creating comprehensive medical device submissions. This streamlining of procedures not only improves efficiency but can also reduce the time and resources needed for the clearance process. <\/span><span style=\"font-weight: 400;\"><br \/><\/span><span style=\"font-weight: 400;\">\u00a0\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">No e-Copy Validation Requirement: Unlike other submission methods, eSTAR does not mandate e-Copy validation, further simplifying the submission process for applicants. <\/span><\/li><\/ol>\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<div class=\"elementor-element elementor-element-0cae3f6 e-flex e-con-boxed e-con e-parent\" data-id=\"0cae3f6\" 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-5b8ab37 elementor-widget elementor-widget-heading\" data-id=\"5b8ab37\" 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 Can Help You<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5322320 elementor-widget elementor-widget-text-editor\" data-id=\"5322320\" 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 data-start=\"9162\" data-end=\"9294\">Operon Strategist supports medical device manufacturers, startups, and importers with end-to-end FDA regulatory consulting services.<\/p><h4 data-section-id=\"l9e8w0\" data-start=\"9296\" data-end=\"9334\">Our FDA Consulting Services Include<\/h4><h5 data-section-id=\"y0fp6k\" data-start=\"9336\" data-end=\"9369\"><a href=\"https:\/\/operonstrategist.com\/elevateplus\/us-fda-510k-qsmr-registration\/\">FDA 510(k)<\/a> Submission Support<\/h5><p data-start=\"9370\" data-end=\"9428\">We help prepare and review complete FDA eSTAR submissions.<\/p><h5 data-section-id=\"zr3ik6\" data-start=\"9430\" data-end=\"9465\">Regulatory Strategy Development<\/h5><p data-start=\"9466\" data-end=\"9535\">Our experts identify the correct FDA pathway and submission strategy.<\/p><h5 data-section-id=\"1xdg6tc\" data-start=\"9537\" data-end=\"9571\"><a href=\"https:\/\/operonstrategist.com\/buildnext\/product-feasibility\/\">Product Feasibility Assessment<\/a><\/h5><p data-start=\"9572\" data-end=\"9640\">We evaluate technical and regulatory feasibility before development.<\/p><h5 data-section-id=\"1aztt9r\" data-start=\"9642\" data-end=\"9686\">Quality Management System Implementation<\/h5><p data-start=\"9687\" data-end=\"9732\">Support for <a href=\"https:\/\/operonstrategist.com\/elevateplus\/quality-management-system-qms\/\">ISO 13485 and FDA QMS compliance<\/a>.<\/p><h5 data-section-id=\"t2qvax\" data-start=\"9734\" data-end=\"9767\"><a href=\"https:\/\/operonstrategist.com\/buildnext\/product-process-engineering-for-manufacturing\/\">Product &amp; Process Engineering<\/a><\/h5><p data-start=\"9768\" data-end=\"9824\">We help optimize manufacturing and compliance workflows.<\/p><h5 data-section-id=\"tpcxub\" data-start=\"9826\" data-end=\"9861\"><a href=\"https:\/\/operonstrategist.com\/buildnext\/plant-layout-detail-engineering\/\">Plant Layout Detail Engineering<\/a><\/h5><p data-start=\"9862\" data-end=\"9926\">Support for FDA-compliant manufacturing infrastructure planning.<\/p><h5 data-section-id=\"1dfys9r\" data-start=\"9928\" data-end=\"9964\">Gap Assessment and Documentation<\/h5><p data-start=\"9965\" data-end=\"10040\">We identify missing documents and technical deficiencies before submission.<\/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<div class=\"elementor-element elementor-element-1d13652e e-con-full e-flex e-con e-child\" data-id=\"1d13652e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6405ae9b elementor-widget elementor-widget-heading\" data-id=\"6405ae9b\" 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\">FAQ<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-781ba1fb elementor-widget elementor-widget-n-accordion\" data-id=\"781ba1fb\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2010\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2010\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Is FDA eSTAR mandatory for FDA 510(k) submissions? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2010\" class=\"elementor-element elementor-element-784d3574 e-con-full e-flex e-con e-child\" data-id=\"784d3574\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-23bdb169 elementor-widget elementor-widget-text-editor\" data-id=\"23bdb169\" 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 data-start=\"10420\" data-end=\"10515\">Yes. Since October 1, 2023, eSTAR is mandatory for most FDA 510(k) submissions unless exempted.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2011\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2011\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What is the purpose of FDA eSTAR Submission? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2011\" class=\"elementor-element elementor-element-83be0e9 e-con-full e-flex e-con e-child\" data-id=\"83be0e9\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d83f0cc elementor-widget elementor-widget-text-editor\" data-id=\"d83f0cc\" 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 data-start=\"10571\" data-end=\"10680\">FDA eSTAR standardizes medical device submissions and improves submission completeness for faster FDA review.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2012\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2012\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What documents are required for FDA eSTAR Submission? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2012\" class=\"elementor-element elementor-element-6b06d071 e-con-full e-flex e-con e-child\" data-id=\"6b06d071\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-665d560a elementor-widget elementor-widget-text-editor\" data-id=\"665d560a\" 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 data-start=\"10923\" data-end=\"10949\">Typical documents include:<\/p><ul data-start=\"10950\" data-end=\"11091\"><li data-section-id=\"3io2t2\" data-start=\"10950\" data-end=\"10970\">Device description<\/li><li data-section-id=\"2yh1fn\" data-start=\"10971\" data-end=\"10988\">Testing reports<\/li><li data-section-id=\"v3ay32\" data-start=\"10989\" data-end=\"10999\">Labeling<\/li><li data-section-id=\"1mrew3x\" data-start=\"11000\" data-end=\"11023\">Risk management files<\/li><li data-section-id=\"1dul2r0\" data-start=\"11024\" data-end=\"11045\">Software validation<\/li><li data-section-id=\"1pjdxg2\" data-start=\"11046\" data-end=\"11068\">Sterility validation<\/li><li data-section-id=\"q47eeg\" data-start=\"11069\" data-end=\"11091\">Predicate comparison<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2013\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"4\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2013\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> How long does FDA eSTAR review take? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2013\" class=\"elementor-element elementor-element-1941b795 e-con-full e-flex e-con e-child\" data-id=\"1941b795\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-733543bf elementor-widget elementor-widget-text-editor\" data-id=\"733543bf\" 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 data-start=\"11139\" data-end=\"11162\">FDA typically performs:<\/p><ul data-start=\"11163\" data-end=\"11258\"><li data-section-id=\"1in88yj\" data-start=\"11163\" data-end=\"11190\">RTA review within 15 days<\/li><li data-section-id=\"12fgxr0\" data-start=\"11191\" data-end=\"11226\">Substantive review within 60 days<\/li><li data-section-id=\"1f2d9pt\" data-start=\"11227\" data-end=\"11258\">Final decision around 90 days<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<script type=\"application\/ld+json\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"Is FDA eSTAR mandatory for FDA 510(k) submissions?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Yes. Since October 1, 2023, eSTAR is mandatory for most FDA 510(k) submissions unless exempted.\"}},{\"@type\":\"Question\",\"name\":\"What is the purpose of FDA eSTAR Submission?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"FDA eSTAR standardizes medical device submissions and improves submission completeness for faster FDA review.\"}},{\"@type\":\"Question\",\"name\":\"What documents are required for FDA eSTAR Submission?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Typical documents include:Device descriptionTesting reportsLabelingRisk management filesSoftware validationSterility validationPredicate comparison\"}},{\"@type\":\"Question\",\"name\":\"How long does FDA eSTAR review take?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"FDA typically performs:RTA review within 15 daysSubstantive review within 60 daysFinal decision around 90 days\"}}]}<\/script>\n\t\t\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 eSTAR? Starting October 1, 2023, all 510(k) submissions, unless exempt, are required to be electronically filed through eSTAR. This electronic system is specifically tailored as an interactive PDF document for assembling a comprehensive pre-market submission of medical devices intended for FDA 510(k) clearance within the United States. Additionally, eSTAR offers a resource for [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":6430,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[22],"tags":[],"class_list":["post-6429","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-us-fda"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/posts\/6429","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/comments?post=6429"}],"version-history":[{"count":0,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/posts\/6429\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/media\/6430"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/media?parent=6429"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/categories?post=6429"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/tags?post=6429"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}