{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Ff56eb26b-e5b6-4e5d-bf3c-d876123f3f99","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=\"Evaluating FDA\u2019s \u201cNew\u201d Proposed Fast-Track Alternative Approach to the 510(k) Pathway\" frameborder=\"0\" scrolling=\"no\" allow=\"clipboard-write\" seamless src=\"http://player.captivate.fm/episode/f56eb26b-e5b6-4e5d-bf3c-d876123f3f99\"></iframe>","title":"Evaluating FDA\u2019s \u201cNew\u201d Proposed Fast-Track Alternative Approach to the 510(k) Pathway","description":"This past month, the FDA drafted a guidance on a quick path to approval as an alternative to the 510(k). The question is, is this really anything new? Today, we\u2019ll be talking to Mike Drues, president of Vascular Sciences, and he\u2019s going to help us all understand what\u2019s different about this fast track and how it might benefit you.\n\nSome of the highlights of the show include:\n\n\u25cf\tWhat the new draft is about and how long this fast track has really been around. \n\u25cf\tSome thoughts on the ramifications for the FDA and medical device companies since President Trump came into office.\n\u25cf\tThe FDA\u2019s revised definition of \u201cleast burdensome.\u201d\n\u25cf\tWhy, despite increased marketing and hype, the \u201cnew\u201d path is not really new at all.\n\u25cf\tWhat \u201cabbreviated\u201d means in this case and why it doesn\u2019t necessarily mean faster or easier.\n\u25cf\tSome questions to ask yourself if you want to know if you are working on something new or novel.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/b88c10e3-a115-4d1c-b8f8-332dbc9f3417/063ece00-90d2-42cc-b617-12800c47f58b.jpg"}