{"id":4461,"date":"2019-03-26T10:10:21","date_gmt":"2019-03-26T13:10:21","guid":{"rendered":"http:\/\/passarini.com.br\/rdc-no-270_2019-notification-of-risk-class-i-medical-devices-2\/"},"modified":"2021-12-20T12:21:01","modified_gmt":"2021-12-20T15:21:01","slug":"possibility-of-reducing-fda-registration-fees-for-medical-devices","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/possibility-of-reducing-fda-registration-fees-for-medical-devices\/","title":{"rendered":"Possibility of reducing FDA registration fees for medical devices"},"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=\"http:\/\/passarini.com.br\/wp-content\/uploads\/2017\/06\/1920x500_informativos_noticias.png\" \/><\/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\"><p><strong>Possibility of reducing FDA registration fees for medical devices<\/strong><\/p>\n<p>Like <a href=\"https:\/\/passarini.com.br\/en\/portfolio-items\/anvisa-registrationrecord\">ANVISA<\/a>, <a href=\"https:\/\/passarini.com.br\/en\/portfolio-items\/fda-registration\/\">FDA<\/a> allows different medical device registration fee values to be applied according to the company&#8217;s annual revenue. This benefit is granted to both American and foreign companies.<\/p>\n<p>Medical device manufacturers whose annual billing is less than $ 100 million are likely to declare themselves a &#8220;Small Business&#8221; and can benefit from a substantial discount. To apply for it, it is necessary to send a formal request to FDA.\u00a0<span style=\"color: #000000;\"><strong>Passarini Regulatory Affairs<\/strong><\/span>\u00a0can help you, contact us.<\/p>\n<p>For a 510 (k) process, the fee reduction obtained reaches almost 76% of the standard value as can be seen in the comparative table below, which shows the standard fee and reduced fee values by submission type.<\/p>\n<table border=\"0\" cellspacing=\"0\" cellpadding=\"0\" align=\"center\">\n<tbody>\n<tr>\n<td rowspan=\"2\"><span style=\"color: #000000;\"><strong>Submission type<\/strong><\/span><\/td>\n<td colspan=\"2\"><span style=\"color: #000000;\"><strong>Fee FY<\/strong>\u00a0<strong>2019 ($)<\/strong><\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"color: #000000;\"><strong>Standard<\/strong><\/span><\/td>\n<td><span style=\"color: #000000;\"><strong>Small Business<\/strong><\/span><\/td>\n<\/tr>\n<tr>\n<td><strong>510(k)<\/strong><\/td>\n<td>10,953<\/td>\n<td>2,642<\/td>\n<\/tr>\n<tr>\n<td><strong>513(g)<\/strong><\/td>\n<td>4,349<\/td>\n<td>2,098<\/td>\n<\/tr>\n<tr>\n<td><strong>PMA\/PDP\/PMR\/BLA<\/strong><\/td>\n<td>322,147<\/td>\n<td>77,691<\/td>\n<\/tr>\n<tr>\n<td><strong>De Novo<\/strong><\/td>\n<td>96,644<\/td>\n<td>23,367<\/td>\n<\/tr>\n<tr>\n<td><strong>PMA Annual Report<\/strong><\/td>\n<td>11,275<\/td>\n<td>2,719<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<div><\/div>\n<p>This fee reduction is valid for the current fiscal year, which began on October 1 2018 and will run through September 30 2019.<\/p>\n<p>For registration processes to be submitted after September 30, a new Small Business request must be made.<\/p>\n<p>Note that the benefit of fee reduction for businesses qualified as Small Business is not applicable to the Establishment annual fee, which for fiscal year 2019 is of $ 4,884.<\/p>\n<p>The FDA guidance on this topic is available at the link below:<\/p>\n<p><span style=\"color: #0000ff;\"><em><u><strong><a style=\"color: #0000ff;\" href=\"http:\/\/passarini.com.br\/wp-content\/uploads\/2019\/03\/Medical-Device-User-Fee-Small-Business-Qualification-and-Certification.pdf\">C<\/a><\/strong><\/u><\/em><a style=\"color: #0000ff;\" href=\"http:\/\/passarini.com.br\/wp-content\/uploads\/2019\/03\/Medical-Device-User-Fee-Small-Business-Qualification-and-Certification.pdf\"><em><u><strong>lick here<\/strong><\/u><\/em><\/a><\/span><\/p>\n<p>For more information and explanations about it, send us an e-mail:\u00a0<strong><span style=\"color: #0000ff;\"><a style=\"color: #0000ff;\" href=\"mailto:contato@passarini.com.br\">contato@passarini.com.br<\/a><\/span><\/strong><\/p>\n<p><span style=\"color: #000000;\"><strong>Passarini Regulatory Affairs<\/strong><\/span><\/p>\n<p>Published: 03\/26\/2019<\/p>\n<\/div><div class=\"fusion-sharing-box fusion-sharing-box-1 boxed-icons has-taglines layout-floated layout-medium-floated layout-small-floated\" style=\"background-color:#f6f6f6;--awb-layout:row;--awb-alignment-small:space-between;\" data-title=\"Passarini Regulatory Affairs\" data-description=\"Possibility of reducing FDA registration fees for medical devices\r\n\r\nLike ANVISA, FDA allows different medical device registration fee values to be applied according to the company&#039;s annual revenue. This benefit is granted to both American and foreign companies.\r\n\r\nMedical device manufacturers whose annual billing is less than $ 100 million are\" data-link=\"http:\/\/passarini.com.br\/en\/possibility-of-reducing-fda-registration-fees-for-medical-devices\/\"><h4 class=\"tagline\" style=\"color:#333333;\">To share<\/h4><div class=\"fusion-social-networks sharingbox-shortcode-icon-wrapper sharingbox-shortcode-icon-wrapper-1 boxed-icons\"><span><a href=\"https:\/\/www.facebook.com\/sharer.php?u=http%3A%2F%2Fpassarini.com.br%2Fen%2Fpossibility-of-reducing-fda-registration-fees-for-medical-devices%2F&amp;t=Passarini%20Regulatory%20Affairs\" target=\"_blank\" rel=\"noreferrer\" title=\"Facebook\" aria-label=\"Facebook\" data-placement=\"top\" data-toggle=\"tooltip\" data-title=\"Facebook\"><i class=\"fusion-social-network-icon fusion-tooltip fusion-facebook awb-icon-facebook\" style=\"color:#ffffff;background-color:#3b5998;border-color:#3b5998;border-radius:4px;\" 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