{"id":4040,"date":"2025-08-12T10:28:32","date_gmt":"2025-08-12T10:28:32","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=4040"},"modified":"2025-08-13T11:50:18","modified_gmt":"2025-08-13T11:50:18","slug":"fda-mdufa-small-business-benefits-eligibility-and-reduced-fee-options","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/fda-mdufa-small-business-benefits-eligibility-and-reduced-fee-options\/","title":{"rendered":"FDA MDUFA Small Business Benefits: eligibility and reduced fee options"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p>The <strong>Medical Device User Fee Amendments (MDUFA)<\/strong> authorize the FDA to collect user fees for certain types of medical device submissions and for the annual establishment registration.<br \/>\nFor small companies in the sector, these costs can be reduced\u2014or in some cases completely waived\u2014through the <strong>Small Business Determination (SBD)<\/strong> Program managed by the <em>Center for Devices and Radiological Health<\/em> (CDRH).<\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_74 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Alternar tabla de contenidos\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/cmcmedicaldevices.com\/es\/fda-mdufa-small-business-benefits-eligibility-and-reduced-fee-options\/#Determining_small_business_status\" >Determining small business status<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/cmcmedicaldevices.com\/es\/fda-mdufa-small-business-benefits-eligibility-and-reduced-fee-options\/#Reduced_fees_for_eligible_businesses\" >Reduced fees for eligible businesses<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/cmcmedicaldevices.com\/es\/fda-mdufa-small-business-benefits-eligibility-and-reduced-fee-options\/#Fee_waivers_for_the_first_major_application\" >Fee waivers for the first major application<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/cmcmedicaldevices.com\/es\/fda-mdufa-small-business-benefits-eligibility-and-reduced-fee-options\/#Fiscal_year_2026_annual_establishment_registration_fee_waiver\" >Fiscal year 2026 annual establishment registration fee waiver<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"Determining_small_business_status\"><\/span>Determining small business status<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>To access reduced fees, a company must submit a <strong>Small Business Request (SBR)<\/strong>. Through this process, the FDA verifies whether the business meets the SBD Program requirements.<br \/>\nEligibility depends on the company\u2019s annual gross receipts or sales and applies to specific types of CDRH submissions.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Reduced_fees_for_eligible_businesses\"><\/span>Reduced fees for eligible businesses<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Small businesses with <strong>gross receipts or sales of $100 million or less<\/strong> may qualify for reduced fees on the following submissions:<\/p>\n<ul>\n<li><strong>Premarket Notification (510(k))<\/strong><\/li>\n<li><strong>De Novo request<\/strong><\/li>\n<li><strong>Premarket Applications<\/strong> (Premarket Approval Application \u2013 PMA, Biologics License Application \u2013 BLA, Product Development Protocol \u2013 PDP, Premarket Report \u2013 PMR)<\/li>\n<li><strong>PMA\/BLA supplements<\/strong> and <strong>PMA annual reports<\/strong><\/li>\n<li><strong>513(g) request<\/strong> for classification information<\/li>\n<\/ul>\n<p>The reduction applies only if the company is officially qualified through the SBD Program.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Fee_waivers_for_the_first_major_application\"><\/span>Fee waivers for the first major application<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Businesses with <strong>gross receipts or sales of $30 million or less<\/strong> may be eligible for a <strong>full fee waiver<\/strong> on their <strong>first<\/strong> PMA, PDP, PMR, or BLA submission.<br \/>\nThis waiver applies exclusively to the first qualifying submission after SBD Program approval.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Fiscal_year_2026_annual_establishment_registration_fee_waiver\"><\/span>Fiscal year 2026 annual establishment registration fee waiver<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Starting in <strong>Fiscal Year 2026<\/strong>, certain small businesses may also qualify for a waiver of the<br \/>\n<strong>Annual Establishment Registration Fee<\/strong> if:<\/p>\n<ul>\n<li>The company and its affiliates have <strong>gross receipts or sales of $1 million or less<\/strong>.<\/li>\n<li>Paying the fee would represent a <strong>financial hardship<\/strong> (e.g., active bankruptcy with documented proof).<\/li>\n<li>The company can provide <strong>proof of prior year\u2019s payment<\/strong> of the registration fee.<\/li>\n<\/ul>\n<p>This measure is intended to support very small businesses facing significant financial challenges.<\/p>\n<p><strong>Need an FDA Agent or assistance with medical device registration?<br \/>\n<\/strong><br \/>\nWe can act as your official <a href=\"https:\/\/cmcmedicaldevices.com\/services\/representation-usa\/\" target=\"_blank\" rel=\"noopener noreferrer\"><b><u>FDA Agent<\/u><\/b><\/a> and manage your medical device registration process, ensuring compliance with all FDA submission and establishment requirements.<\/p>\n<\/div><div style=\"text-align:center;\"><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" style=\"--button_margin-top:10px;--button_margin-bottom:20px;\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/cmcmedicaldevices.com\/contact\/\"><span class=\"fusion-button-text\">Contact us for more information<\/span><\/a><\/div><div class=\"fusion-image-element \" style=\"text-align:center;--awb-max-width:600px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"1640\" height=\"924\" alt=\"FDA MDUFA Small Business Benefits_\" title=\"FDA MDUFA Small Business Benefits_\" src=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/08\/FDA-MDUFA-Small-Business-Benefits_.jpg\" class=\"img-responsive wp-image-4042\" srcset=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/08\/FDA-MDUFA-Small-Business-Benefits_-200x113.jpg 200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/08\/FDA-MDUFA-Small-Business-Benefits_-400x225.jpg 400w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/08\/FDA-MDUFA-Small-Business-Benefits_-600x338.jpg 600w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/08\/FDA-MDUFA-Small-Business-Benefits_-800x451.jpg 800w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/08\/FDA-MDUFA-Small-Business-Benefits_-1200x676.jpg 1200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/08\/FDA-MDUFA-Small-Business-Benefits_.jpg 1640w\" sizes=\"(max-width: 640px) 100vw, 1200px\" \/><\/span><\/div><\/div><\/div><\/div><\/div>\n\n\n<div class=\"kk-star-ratings kksr-auto kksr-align-center kksr-valign-bottom\"\n    data-payload='{&quot;align&quot;:&quot;center&quot;,&quot;id&quot;:&quot;4040&quot;,&quot;slug&quot;:&quot;default&quot;,&quot;valign&quot;:&quot;bottom&quot;,&quot;ignore&quot;:&quot;&quot;,&quot;reference&quot;:&quot;auto&quot;,&quot;class&quot;:&quot;&quot;,&quot;count&quot;:&quot;7&quot;,&quot;legendonly&quot;:&quot;&quot;,&quot;readonly&quot;:&quot;&quot;,&quot;score&quot;:&quot;5&quot;,&quot;starsonly&quot;:&quot;&quot;,&quot;best&quot;:&quot;5&quot;,&quot;gap&quot;:&quot;5&quot;,&quot;greet&quot;:&quot;Rate this&quot;,&quot;legend&quot;:&quot;5\\\/5 - (7 votos)&quot;,&quot;size&quot;:&quot;24&quot;,&quot;title&quot;:&quot;FDA MDUFA Small Business Benefits: eligibility and reduced fee options&quot;,&quot;width&quot;:&quot;142.5&quot;,&quot;_legend&quot;:&quot;{score}\\\/{best} - ({count} {votes})&quot;,&quot;font_factor&quot;:&quot;1.25&quot;}'>\n            \n<div class=\"kksr-stars\">\n    \n<div class=\"kksr-stars-inactive\">\n            <div class=\"kksr-star\" data-star=\"1\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"2\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"3\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"4\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"5\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n    \n<div class=\"kksr-stars-active\" style=\"width: 142.5px;\">\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n<\/div>\n                \n\n<div class=\"kksr-legend\" style=\"font-size: 19.2px;\">\n            5\/5 - (7 votos)    <\/div>\n    <\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"gallery","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4040","post","type-post","status-publish","format-gallery","hentry","category-sin-categorizar","post_format-post-format-gallery"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.3.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA MDUFA Small Business Benefits: Reduced and Waived Fees<\/title>\n<meta name=\"description\" content=\"FDA MDUFA small business 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