{"id":16025,"date":"2024-11-06T10:08:54","date_gmt":"2024-11-06T09:08:54","guid":{"rendered":"http:\/\/lsacademy.com\/?post_type=product&#038;p=16025"},"modified":"2025-10-20T13:11:36","modified_gmt":"2025-10-20T12:11:36","slug":"pre-market-submission-of-medical-devices-to-the-us-fda-navigating-the-pre-sub-and-510k-process","status":"publish","type":"product","link":"https:\/\/lsacademy.com\/it\/product\/pre-market-submission-of-medical-devices-to-the-us-fda-navigating-the-pre-sub-and-510k-process\/","title":{"rendered":"Pre-Market Submission of Medical Devices to the US FDA: Navigating the Pre-Sub and 510(k) Process"},"content":{"rendered":"<p>Do you want to bring a medical device to the US market, but feel you are entering a jungle of regulatory processes and requirements that are difficult to navigate and understand?<\/p>\n<p>These are questions that sound all too familiar:<\/p>\n<ul>\n<li>What is the 510(k) procedure and how is it different from a Pre-Market Application (PMA)?<\/li>\n<li>What is the Code of Federal Regulations (CFRs) and how does it affect the general and special requirements of specific classes of medical devices?<\/li>\n<li>What are the 3-letter product codes assigned to devices and what do they mean?<\/li>\n<li>What is a Q-Sub? How and when is a Q-sub useful?<\/li>\n<\/ul>\n<p>Let\u2019s start with untangling nomenclature and understanding how the United States Food and Drug Administration (US FDA) regulates medical devices.<\/p>\n<p>This workshop takes a deep dive into the fundamentals of the US FDA regulatory framework and identifies the difference in approach to EU requirements.<\/p>\n<p>We will use interactive case studies to better understand the practical applications of the different possible submission pathways and processes.<br \/>\nWe will discuss the basic expectations of the 510(k) procedure and pre-submission packets: what does and doesn\u2019t belong in a pre-submission and what the manufacturer and FDA expectations are in a pre-submission meeting.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Do you want to bring a medical device to the US market, but feel you are entering a jungle of regulatory processes and requirements that are difficult to navigate and understand? These are questions that sound all too familiar: What is the 510(k) procedure and how is it different from a Pre-Market Application (PMA)? What &hellip; <a href=\"https:\/\/lsacademy.com\/it\/product\/pre-market-submission-of-medical-devices-to-the-us-fda-navigating-the-pre-sub-and-510k-process\/\">Continued<\/a><\/p>\n","protected":false},"featured_media":11513,"template":"","meta":[],"product_brand":[],"product_cat":[46],"product_tag":[],"class_list":["post-16025","product","type-product","status-publish","has-post-thumbnail","course_topics-dispositivi-medici","course_topics-regolatorio","course_types-corso-online","productgroup-medical-device-us-fda-pre-market-submissions","product_cat-corsi","first","instock","taxable","shipping-taxable","purchasable","product-type-variable"],"_links":{"self":[{"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/product\/16025","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/media\/11513"}],"wp:attachment":[{"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/media?parent=16025"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/product_brand?post=16025"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/product_cat?post=16025"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/lsacademy.com\/it\/wp-json\/wp\/v2\/product_tag?post=16025"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}