{"id":12986,"date":"2023-10-27T14:35:09","date_gmt":"2023-10-27T13:35:09","guid":{"rendered":"http:\/\/lsacademy.com\/?post_type=product&#038;p=12986"},"modified":"2024-09-26T16:55:53","modified_gmt":"2024-09-26T15:55:53","slug":"fundamentals-of-medical-device-us-fda-pre-submission","status":"publish","type":"product","link":"https:\/\/lsacademy.com\/en\/product\/fundamentals-of-medical-device-us-fda-pre-submission\/","title":{"rendered":"US FDA 101 &#8211; Fundamentals of Pre-market Submissions to CDRH"},"content":{"rendered":"<ul>\n<li>What is the 510(k) and how is it different from a Pre-market application (PMA)?<\/li>\n<li>What are the Code of Federal Regulations (CFRs) and how do they affect the general and special requirements of specific medical devices?<\/li>\n<li>What are the 3-letter product codes assigned to devices and what do they mean?<\/li>\n<li>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 identify the difference in approach to EU requirements.<\/p>\n<p>We will use interactive case studies to better understand the practical applications of the submission pathway and process and discuss the basic expectations of the 510(k) and Pre-submission packets &#8211; what does and doesn\u2019t belong in a Pre-Submission? What are the manufacturer and FDA expectations in a Pre-submission meeting?<\/p>\n","protected":false},"excerpt":{"rendered":"<p>What is the 510(k) and how is it different from a Pre-market application (PMA)? What are the Code of Federal Regulations (CFRs) and how do they affect the general and special requirements of specific medical devices? What are the 3-letter product codes assigned to devices and what do they mean? How and when is a &hellip; <a href=\"https:\/\/lsacademy.com\/en\/product\/fundamentals-of-medical-device-us-fda-pre-submission\/\">Continued<\/a><\/p>\n","protected":false},"featured_media":11513,"template":"","meta":[],"product_brand":[],"product_cat":[46],"product_tag":[],"class_list":["post-12986","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\/12986","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=12986"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product_brand?post=12986"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product_cat?post=12986"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product_tag?post=12986"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}