{"id":301,"date":"2025-08-11T20:27:00","date_gmt":"2025-08-11T20:27:00","guid":{"rendered":"https:\/\/www.libertymanagement.us\/fda-news\/?p=301"},"modified":"2025-08-11T20:27:00","modified_gmt":"2025-08-11T20:27:00","slug":"fda-small-business-determination-sbd-an-overview","status":"publish","type":"post","link":"https:\/\/www.libertymanagement.us\/fda-news\/2025\/08\/11\/fda-small-business-determination-sbd-an-overview\/","title":{"rendered":"FDA SMALL BUSINESS DETERMINATION (SBD) \u2013 AN OVERVIEW"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">FDA defines \u201csmall business\u201d which includes all its\naffiliates with gross sales or earnings not exceeding $100 million, $30\nmillion, or $1 million, for the most recent tax year, are eligible for small\nbusiness fee waivers.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Qualified small businesses, with all affiliates with gross earnings\nof not more than $100 million are eligible for reduced fees for certain type of\nCDRH submissions that are required to pay user fee by the businesses.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Below are the application types that are eligible for reduced\nsmall business fees.<\/p>\n\n\n\n<ol class=\"wp-block-list\"><li><a href=\"https:\/\/www.fdahelp.us\/premarket-submission-510k.html\">Premarket\nNotification (510K)<\/a><\/li><li>De Novo request<\/li><li>Premarket Approval Application<\/li><li>Biologics License Application (BLA)<\/li><li>Product development Protocol (PDP)<\/li><li>Premarket Reporting (PMR)<\/li><li>PMA\/BLA supplements and PMA annual reports<\/li><li>30-day-Notices<\/li><li>513(g) Requests for Information<\/li><\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">Small business is eligible for \u201cFirst premarket\napplication\/report\u201d fee waives if the business and affiliate gross income are\nno more than $30 million for first their PMA, PDP, PMR, or BLA application.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">FDA has introduced a new small business fee waiver program\nfor <a href=\"https:\/\/www.fdahelp.us\/fda-fees-2026.html\">MDUFA fees<\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This fee waiver is not applicable for initial registration. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Companies are eligible for small business fee waivers if\nthey satisfy all the requirements below.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>business,\n     including its affiliates, has gross receipts or sales of $1 million or\n     less in the most recent tax year,<\/li><li>Must prove\n     that paying the registration fee would represent a financial hardship (for\n     example, proof your business is in active bankruptcy), and<\/li><li>Proof\n     that they had paid the registration fee in a prior fiscal year.<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">To apply for SBD, companies must get organization ID and\nsubmit form 3602N to FDA.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"http:\/\/www.fdahelp.us\/\">Liberty Management Group Ltd<\/a>, as leading FDA consultants will provide assistance in creating user fee account, completing and checking form 3602N and providing assistance with <a href=\"https:\/\/www.fdahelp.us\/establishment-registration.html\">Medical device establishment registration<\/a> and <a href=\"https:\/\/www.fdahelp.us\/medical_device_registration_renewal.html\">renewals<\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sudha S<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Regulatory Consultant<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Email: office@libertymanagement.us<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"http:\/\/www.fdahelp.us\">www.fdahelp.us<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA defines \u201csmall business\u201d which includes all its affiliates with gross sales or earnings not exceeding $100 million, $30 million, or $1 million, for the most recent tax year, are eligible for small business fee waivers. Qualified small businesses, with all affiliates with gross earnings of not more than $100 million are eligible for reduced &hellip; <a href=\"https:\/\/www.libertymanagement.us\/fda-news\/2025\/08\/11\/fda-small-business-determination-sbd-an-overview\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA SMALL BUSINESS DETERMINATION (SBD) \u2013 AN OVERVIEW&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[27],"tags":[29],"class_list":["post-301","post","type-post","status-publish","format-standard","hentry","category-fda-registration-medical-device","tag-fda-medical-device-registration"],"_links":{"self":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/301","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/comments?post=301"}],"version-history":[{"count":1,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/301\/revisions"}],"predecessor-version":[{"id":302,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/301\/revisions\/302"}],"wp:attachment":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/media?parent=301"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/categories?post=301"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/tags?post=301"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}