{"id":16715,"date":"2020-11-24T11:56:34","date_gmt":"2020-11-24T10:56:34","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=16715"},"modified":"2023-01-24T14:59:04","modified_gmt":"2023-01-24T13:59:04","slug":"usa-cdrh-guidelines-for-fiscal-year-2021-fy-2021","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/en\/2020\/11\/24\/usa-cdrh-guidelines-for-fiscal-year-2021-fy-2021\/","title":{"rendered":"USA: CDRH guidelines for fiscal year 2021 (FY 2021)"},"content":{"rendered":"\n<p>On 16 October 2020 the <strong>Center for Devices and Radiological Health (CDRH)<\/strong> of FDA published the list of guidelines it intends to publish for fiscal year 2021 <strong>(FY 2021)<\/strong>.<br>Moreover, CDRH also announced that it undertakes to review the final guidelines previously published and to update or delete those documents that no longer represent the current FDA view on a given regulatory issue.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/11\/usa-linee-guida-cdrh-fy-2021-1024x536.jpg\" alt=\"CDRH guidelines for fiscal year 2021 (FY 2021) USA\" class=\"wp-image-16691\"\/><figcaption>CDRH guidelines for fiscal year 2021 (FY 2021)<\/figcaption><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>CDRH guidelines in 3 lists<\/strong><\/h2>\n\n\n\n<p>The CDRH has decided to divide the guidelines\ninto 3 lists:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>The A-list:<\/strong>&nbsp;guidelines\nthat FDA intends to publish;<\/li><li><strong>The B-list:<\/strong>&nbsp;documents that FDA intends\nto publish as permitted resources during FY 2021;<\/li><li><strong>Retrospective <\/strong><strong>review list:<\/strong>&nbsp;final guidelines published in 1981, 1991,\n2001 and 2011 which are subject to retrospective review.<\/li><\/ul>\n\n\n\n<p>Some guidelines planned for 2021 concern the Safer Technologies program (STeP) for medical devices, clinical decision software (CDS) and documents based on the safety and performance of medical devices. It is possible to consult the complete list by linking to the following link: <a href=\"https:\/\/www.fda.gov\/medical-devices\/guidance-documents-medical-devices-and-radiation-emitting-products\/cdrh-proposed-guidances-fiscal-year-2021-fy-2021?utm_medium=email&amp;utm_source=govdelivery\">CDRH Proposed Guidances for Fiscal Year 2021 (FY 2021)<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>FY 2021: Did you renew the Establishment Registration?<\/strong><\/h2>\n\n\n\n<p>Each year FDA requires the payment of an <strong>annual fee<\/strong> for the renewal of the <strong>Establishment Registration <\/strong>and <strong>Device Listing<\/strong>, as required by the <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?CFRPart=807\">21 CFR Part 807<\/a>.<br>There is little time: <strong>by December 31, 2020<\/strong> it is necessary to carry out this renewal at FDA for the next year (2021).<br>The tax for fiscal year 2021 is $ 5,546 (U.S.) for each establishment and <strong>there are no exemptions or reductions<\/strong>: all establishments must may the registration fee. In addition, all information related to the Establishment Registration shall be sent in electronic form.<\/p>\n\n\n\n<p class=\"has-medium-font-size\"><strong>Do you need help? Contact\nus for a consultation!<\/strong><strong><\/strong><\/p>\n\n\n\n<p>Thema can support you in the task and perform all the formalities required by FDA for this renewal. Moreover, we remind you that, thanks to THEMA USA and to strategic partnerships, THEMA also offers the service of U.S. Agent and <a href=\"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/us-initial-importer-service\/\">U.S. Initial Importer<\/a>.<\/p>\n\n\n\n<p><strong>Do not waste any more time! Discover our <a href=\"https:\/\/www.thema-med.com\/en\/services\/\">Services<\/a> &nbsp;and <\/strong><a href=\"mailto:sales@thema-group.it\"><strong>Contact us <\/strong><\/a><strong>! <\/strong><\/p>\n\n\n\n<p><em>Sources:&nbsp;<\/em><\/p>\n\n\n\n<p><a href=\"https:\/\/www.fda.gov\/medical-devices\/guidance-documents-medical-devices-and-radiation-emitting-products\/cdrh-proposed-guidances-fiscal-year-2021-fy-2021?utm_medium=email&amp;utm_source=govdelivery\">CDRH Guidances for FY 2021<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/www.fda.gov\/medical-devices\/how-study-and-market-your-device\/device-registration-and-listing\">FDA Establishment Registration e Device Listing \ufeff<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 16 October 2020 the Center for Devices and Radiological Health (CDRH) of FDA published the list of guidelines it intends  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"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":[],"class_list":["post-16715","post","type-post","status-publish","format-standard","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>USA: CDRH guidelines for fiscal year 2021 (FY 2021)<\/title>\n<meta name=\"description\" content=\"FY 2021: FDA renew the Establishment Registration and CDRH published the list of guidelines it intends to publish for fiscal year 2021.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" 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