{"id":19540,"date":"2025-12-10T17:09:15","date_gmt":"2025-12-10T16:09:15","guid":{"rendered":"https:\/\/lsacademy.com\/?post_type=product&#038;p=19540"},"modified":"2026-09-22T14:35:22","modified_gmt":"2026-09-22T13:35:22","slug":"pre-market-submission-of-medical-devices-to-the-us-fda-navigating-the-pre-sub-and-510k-process-2","status":"publish","type":"product","link":"https:\/\/lsacademy.com\/en\/product\/pre-market-submission-of-medical-devices-to-the-us-fda-navigating-the-pre-sub-and-510k-process-2\/","title":{"rendered":"Pre-Market Submission of Medical Devices to the US FDA: Navigating the Pre-Sub and 510(k) Process"},"content":{"rendered":"<h2>Pre-Market Submission of Medical Devices to the US FDA: Navigating the Pre-Sub and 510(k) Process<\/h2>\n<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.<\/p>\n<p>We 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>Pre-Market Submission of Medical Devices to the US FDA: Navigating the Pre-Sub and 510(k) Process 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 &hellip; <a href=\"https:\/\/lsacademy.com\/en\/product\/pre-market-submission-of-medical-devices-to-the-us-fda-navigating-the-pre-sub-and-510k-process-2\/\">Continued<\/a><\/p>\n","protected":false},"featured_media":11513,"template":"","meta":[],"product_brand":[],"product_cat":[46],"product_tag":[],"class_list":["post-19540","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\/en\/wp-json\/wp\/v2\/product\/19540","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/media\/11513"}],"wp:attachment":[{"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/media?parent=19540"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product_brand?post=19540"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product_cat?post=19540"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product_tag?post=19540"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}