{"id":12161,"date":"2024-08-09T13:36:33","date_gmt":"2024-08-09T16:36:33","guid":{"rendered":"https:\/\/passarini.com.br\/?p=12161"},"modified":"2024-08-12T15:35:10","modified_gmt":"2024-08-12T18:35:10","slug":"understand-the-impact-of-the-fda-fee-adjustment-on-your-business","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/understand-the-impact-of-the-fda-fee-adjustment-on-your-business\/","title":{"rendered":"Understand the impact of the FDA fee adjustment on your business"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 hundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-background-position:left center;--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-padding-top:0px;--awb-padding-right:0px;--awb-padding-bottom:0px;--awb-padding-left:0px;--awb-margin-top:0px;--awb-margin-bottom:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"--awb-padding-top:0px;--awb-padding-right:0px;--awb-padding-bottom:0px;--awb-padding-left:0px;--awb-bg-size:cover;--awb-margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-slider-sc fusion-flexslider-loading flexslider flexslider-hover-type-none\" data-slideshow_autoplay=\"1\" data-slideshow_smooth_height=\"0\" data-slideshow_speed=\"7000\" style=\"max-width:100%;height:100%;\"><ul class=\"slides\"><li class=\"image\"><span class=\"fusion-image-hover-element hover-type-none\"><img decoding=\"async\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1.webp\" alt=\"Banner Informativos Blog da Passarini\" width=\"1560\" height=\"406\" class=\"wp-image-8654\" \/><\/span><\/li><\/ul><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 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-padding-top:10px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_3_4 3_4 fusion-three-fourth fusion-column-first\" style=\"--awb-bg-size:cover;width:75%;width:calc(75% - ( ( 4% ) * 0.75 ) );margin-right: 4%;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-text fusion-text-1\"><h2 class=\"headingpostinterno\">FDA Increases Fees by up to 21% for Fiscal Year 2025: What You Need to Know.<\/h2>\n<p>The FDA (Food and Drug Administration) announced on August 1, 2024, the new fees for Fiscal Year 2025 (FY25).<\/p>\n<p>Companies that manufacture or distribute medical devices for the US must register annually with the FDA. This process is called Establishment Registration and it&#8217;s mandatory.<\/p>\n<p>If your company manufactures, distributes, or imports medical devices for the US, even if only for export, annual registration with the <a href=\"https:\/\/pt.wikipedia.org\/wiki\/Food_and_Drug_Administration\">FDA<\/a> is mandatory. Additionally, most registered establishments also need to list their devices and related activities.<\/p>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-text fusion-text-2\"><p>Below is a comparison between fiscal years 2024 and 2025:<\/p>\n<p><strong>Annual Establishment Registration Fee:<\/strong><\/p>\n<ul>\n<li><del>From: USD 7,653.00<\/del><\/li>\n<li>To: <strong>USD 9,280.00<\/strong><\/li>\n<li>Increase: USD 1,627.00 (approximately 21%).<\/li>\n<\/ul>\n<p>For the other fees, the increase was approximately <strong>10,6%.<\/strong><\/p>\n<p>See the table below:<\/p>\n<\/div>\n<div class=\"table-1\">\n<table width=\"100%\">\n<thead>\n<tr>\n<th align=\"left\">Fiscal Year:<\/th>\n<th align=\"left\">2024<\/th>\n<th align=\"left\"><\/th>\n<th align=\"left\">2025<\/th>\n<th align=\"left\"><\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td align=\"left\"><strong>Application Type<\/strong><\/td>\n<td align=\"left\"><strong>Standard Fee<\/strong><\/td>\n<td align=\"left\"><strong>Small Business Fee\u2020<\/strong><\/td>\n<td align=\"left\"><strong>Standard Fee<\/strong><\/td>\n<td align=\"left\"><strong>Small Business Fee\u2020<\/strong><\/td>\n<\/tr>\n<tr>\n<td align=\"left\">510(k)\u2021<\/td>\n<td align=\"left\">$ 21,760.00<\/td>\n<td align=\"left\">$ 5,440.00<\/td>\n<td align=\"left\">$ 24,335.00<\/td>\n<td align=\"left\">$ 6,084.00<\/td>\n<\/tr>\n<tr>\n<td align=\"left\">513(g)<\/td>\n<td align=\"left\">$ 6,528.00<\/td>\n<td align=\"left\">$ 3,264.00<\/td>\n<td align=\"left\">$ 7,301.00<\/td>\n<td align=\"left\">$ 3,650.00<\/td>\n<\/tr>\n<tr>\n<td align=\"left\">PMA, PDP, PMR, BLA<\/td>\n<td align=\"left\">$ 483,560.00<\/td>\n<td align=\"left\">$ 120,890.00<\/td>\n<td align=\"left\">$ 540,783.00<\/td>\n<td align=\"left\">$ 135,196.00<\/td>\n<\/tr>\n<tr>\n<td align=\"left\">De Novo Classification Request<\/td>\n<td align=\"left\">$ 145,068.00<\/td>\n<td align=\"left\">$ 36,267.00<\/td>\n<td align=\"left\">$ 162,235.00<\/td>\n<td align=\"left\">$ 40,559.00<\/td>\n<\/tr>\n<tr>\n<td align=\"left\">Panel-track Supplement<\/td>\n<td align=\"left\">$ 386,848.00<\/td>\n<td align=\"left\">$ 96,712.00<\/td>\n<td align=\"left\">$ 432,626.00<\/td>\n<td align=\"left\">$ 108,157.00<\/td>\n<\/tr>\n<tr>\n<td align=\"left\">180-Day Supplement<\/td>\n<td align=\"left\">$ 72,534.00<\/td>\n<td align=\"left\">$ 18,134.00<\/td>\n<td align=\"left\">$ 81,117.00<\/td>\n<td align=\"left\">$ 20,279.00<\/td>\n<\/tr>\n<tr>\n<td align=\"left\">Real-Time Supplement<\/td>\n<td align=\"left\">$ 33,849.00<\/td>\n<td align=\"left\">$ 8,462.00<\/td>\n<td align=\"left\">$ 37,855.00<\/td>\n<td align=\"left\">$ 9,464.00<\/td>\n<\/tr>\n<tr>\n<td align=\"left\">BLA Efficacy Supplement<\/td>\n<td align=\"left\">$ 483,560.00<\/td>\n<td align=\"left\">$ 120,890.00<\/td>\n<td align=\"left\">$ 540,783.00<\/td>\n<td align=\"left\">$ 135,196.00<\/td>\n<\/tr>\n<tr>\n<td align=\"left\">30-Day Notice<\/td>\n<td align=\"left\">$ 7,737.00<\/td>\n<td align=\"left\">$ 3,869.00<\/td>\n<td align=\"left\">$ 8,653.00<\/td>\n<td align=\"left\">$ 4,326.00<\/td>\n<\/tr>\n<tr>\n<td align=\"left\">Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs)<\/td>\n<td align=\"left\">$ 16,925.00<\/td>\n<td align=\"left\">$ 4,231.00<\/td>\n<td align=\"left\">$ 18,927.00<\/td>\n<td align=\"left\">$ 4,732.00<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n\n<div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-text fusion-text-3\"><p>The FDA (Food and Drug Administration) fiscal year runs from October 1 to September 30 of the following year. Thus, the aforementioned fees refer to the period from October 1, 2024, to September 30, 2025.<\/p>\n<p>For the renewal of the establishment registration (fundamental step for those who want to keep their registration active with the FDA, with the possibility of selling the product in the American market), the fee payment window is between October 1, 2024 and December 31, 2024.<\/p>\n<p class=\"first-token\" data-sourcepos=\"1:1-1:75\"><strong>Passarini Group is committed to facilitating access to the American market.<\/strong><\/p>\n<p data-sourcepos=\"3:1-3:166\">In addition to keeping you informed about updates, we are working to streamline the Small Business certification application process. Stay tuned for news coming soon!<\/p>\n<p>For further information, assistance in the registration or renewal process, Small Business certification, US Agent, 510(k) submission process, and other activities, contact Passarini Group! It will be a pleasure to help you\u00a0via email at: <span style=\"color: #0000ff;\"><strong><a style=\"color: #0000ff;\" href=\"mailto:contato@passarini.com.br?subject=Enquadramento%20de%20porte%20ANVISA\">contato@passarini.com.br<\/a><\/strong><\/span><\/p>\n<h2><span style=\"color: #000000;\"><strong>Passarini Group<\/strong><\/span><\/h2>\n<p>Published on: 08\/09\/2024<\/p>\n<\/div><div class=\"fusion-sharing-box fusion-sharing-box-1 boxed-icons has-taglines layout-floated layout-medium-floated layout-small-stacked\" style=\"background-color:#f6f6f6;--awb-separator-border-sizes:0px;--awb-layout:row;--awb-alignment-small:space-between;--awb-stacked-align-small:center;\" data-title=\"Passarini Group\" data-description=\"FDA Increases Fees by up to 21% for Fiscal Year 2025: What You Need to Know.\r\nThe FDA (Food and Drug Administration) announced on August 1, 2024, the new fees for Fiscal Year 2025 (FY25).\r\n\r\nCompanies that manufacture or distribute medical devices for the US must register annually with the FDA. 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