{"id":18974,"date":"2021-09-21T10:05:20","date_gmt":"2021-09-21T08:05:20","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=18974"},"modified":"2023-12-12T16:07:54","modified_gmt":"2023-12-12T15:07:54","slug":"usa-fda-has-increased-fees-for-2022-medical-devices-companies","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2021\/09\/21\/usa-fda-has-increased-fees-for-2022-medical-devices-companies\/","title":{"rendered":"USA: FDA has increased fees for 2022 fiscal year by 2.5%"},"content":{"rendered":"\r\n<p>The US <strong>Food and Drug Administration (FDA)<\/strong> has published the fee rates corresponding to <strong>fiscal year 2022 (FY2022)<\/strong> starting October 1<sup>st<\/sup> 2021 and ending September 30<sup>th<\/sup>, 2022, envisaging a <strong>2.5%<\/strong> tax <strong>increase<\/strong> for <strong>Medical Devices<\/strong> companies.<\/p>\r\n\r\n\r\n\r\n<p>Therefore, Medical Devices companies are liable to pay these taxes comply with FDA requirements.<\/p>\r\n\r\n\r\n\r\n<figure class=\"wp-block-image\"><img decoding=\"async\" class=\"wp-image-18956\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2021\/09\/usa-fda-aumento-tasse-dispositivi-medici-anno-fiscale-2022-1024x536.jpg\" alt=\"\" \/>\r\n<figcaption>FDA has increased fees for 2022 fiscal year by 2.5%<\/figcaption>\r\n<\/figure>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\"><strong>Standard FDA fees for Medical Devices FY2022<\/strong><\/h2>\r\n\r\n\r\n\r\n<table class=\"wp-block-table\">\r\n<tbody>\r\n<tr>\r\n<td><strong>Application Type<\/strong><\/td>\r\n<td><strong>Standard Fee<\/strong><\/td>\r\n<\/tr>\r\n<tr>\r\n<td>510(k)<\/td>\r\n<td>$ 12,745<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>513(g)<\/td>\r\n<td>$ 5,061<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>PMA, PDP, PMR, BLA<\/td>\r\n<td>$ 374,858<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>De Novo Classification<\/td>\r\n<td>$ 112,457<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>Panel-track Supplement<\/td>\r\n<td>$ 281,143<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>180-day Supplement<\/td>\r\n<td>$ 56,229<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>Real-time Supplement<\/td>\r\n<td>$ 26,240<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>30-day Notice<\/td>\r\n<td>$ 5,998<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>PMA Annual Report<\/td>\r\n<td>$ 13,120<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\"><strong>Small Business FDA fees for Medical Devices FY2022<\/strong><\/h2>\r\n\r\n\r\n\r\n<p>SMEs with a <strong>total turnover of 100 million dollars or less<\/strong> can qualify as <strong>Small Business<\/strong> so they can benefit from <strong>reduced fees<\/strong> for applications. In particular:<\/p>\r\n\r\n\r\n\r\n<table class=\"wp-block-table\">\r\n<tbody>\r\n<tr>\r\n<td><strong>Application Type<\/strong><\/td>\r\n<td><strong>Small Business Fee<\/strong><\/td>\r\n<\/tr>\r\n<tr>\r\n<td>510(k)<\/td>\r\n<td>$ 3,186<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>513(g)<\/td>\r\n<td>$ 2,530<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>PMA, PDP, PMR, BLA<\/td>\r\n<td>$ 93,714<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>De Novo Classification<\/td>\r\n<td>$ 28,114<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>Panel-track Supplement<\/td>\r\n<td>$ 70,286<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>180-day Supplement<\/td>\r\n<td>$ 14,057<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>Real-time Supplement<\/td>\r\n<td>$ 6,560<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>30-day Notice<\/td>\r\n<td>$ 2,999<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>PMA Annual Report<\/td>\r\n<td>$ 3,280<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\"><strong>Establishment registration fee is expected to increase too<\/strong><\/h2>\r\n\r\n\r\n\r\n<p>Compared to 2021 ($ 5,546), for 2022 fiscal year, the <strong>establishment registration<\/strong> fee, which is $ 5,672 for every establishment, is expected to<strong> increase<\/strong> too.<\/p>\r\n\r\n\r\n\r\n<p>In this case though, <strong>it is not possible to benefit from reduced fees or exemptions<\/strong>: every establishment has to pay its own registration fee.<\/p>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\"><strong>Choose Thema to carry out obligations required by FDA<\/strong><\/h2>\r\n\r\n\r\n\r\n<p>Thanks to THEMA USA and strategic partnership with US companies, Thema is able to run every obligation required for 2022 fiscal year by FDA. In addition, it provides <strong><a href=\"http:\/\/www.themausa.net\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"U.S Agent (si apre in una nuova scheda)\">U.S Agent<\/a><\/strong> and <strong><a href=\"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/us-initial-importer-service\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"U.S Initial Importer  (si apre in una nuova scheda)\">U.S Initial Importer<\/a><\/strong> services too.<\/p>\r\n\r\n\r\n\r\n<p>For further information, do not hesitate to <strong><a href=\"mailto:sales@thema-med.com\">contact us<\/a><\/strong>!<\/p>\r\n\r\n\r\n\r\n<p><em>Source:<\/em><\/p>\r\n\r\n\r\n\r\n<p><a href=\"https:\/\/www.federalregister.gov\/documents\/2021\/08\/02\/2021-16408\/medical-device-user-fee-rates-for-fiscal-year-2022?utm_medium=email&amp;utm_source=govdelivery\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">Medical Device User Fee Rates for Fiscal Year 2022, FDA, August 2, 2021<\/a><\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>The US Food and Drug Administration (FDA) has published the fee rates corresponding to fiscal year 2022 (FY2022) starting October 1st  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":23022,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[1568],"class_list":["post-18974","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en","tag-usa-topic"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>USA: FDA has increased fees for 2022 for medical devices 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