{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F79e1807a-2e41-4c8b-a376-77a72a0f8006","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"<iframe style=\"width: 100%; height: 200px;\" title=\"Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission\" frameborder=\"0\" scrolling=\"no\" allow=\"clipboard-write\" seamless src=\"http://player.captivate.fm/episode/79e1807a-2e41-4c8b-a376-77a72a0f8006\"></iframe>","title":"Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission","description":"It can be confusing to know which submission type is the correct one for your particular development situation. Today we\u2019re going to talk to Mike Drues, president of Vascular Sciences and regulatory guru, about what to keep in mind as you decide whether to use the 510(k), De Novo, 513(g), or Pre-Sub process.\n\nSome of the highlights of the show include:\n\n\u25cf\tThe difference between the 510(k) and the De Novo submissions and how to decide between them. \n\u25cf\tAn explanation of why the 510(k) submission process does not include proof of product safety or efficacy.\n\u25cf\tWhy the number of De Novo submissions is so small and what the process entails in terms of proving safety, as well as how it compares to the pre-market approval (PMA) process.\n\u25cf\tHow the relationship between a medical device company and the FDA resembles a poker game.\n\u25cf\tSome statistics on the 510(k) and the PMA: How many are rejected the first time they\u2019re submitted and why.\n\u25cf\tWhen you should do a 513(g) vs. a pre-sub: how the two processes differ and when you should use each.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/64ad1fea-b839-4ac2-9135-effc40ae674e/c9686183-c00a-43a5-a118-e7648ddb4c89.jpg"}