{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F12cae952-d6ec-4f1a-8933-4936c41667da","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=\"What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's So Important\" frameborder=\"0\" scrolling=\"no\" allow=\"clipboard-write\" seamless src=\"http://player.captivate.fm/episode/12cae952-d6ec-4f1a-8933-4936c41667da\"></iframe>","title":"What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's So Important","description":"Do you have a firm grasp and understanding of what substantial equivalence means in regards to the 510(k)?\n\nMany don\u2019t understand it; the evidence is the large percentage of submissions that are rejected due to a lack of demonstrating substantial equivalence.\n\nToday we\u2019re talking with Mike Drues, President of Vascular Sciences about demonstrating substantial equivalence, so if you\u2019re not rock-solid on the concept, you won\u2019t want to miss this episode.\n\nSome of the highlights of the show include:\n\n\u25cf\tExactly what substantial equivalence means as it applies to the regulatory process and why it\u2019s important.\n\u25cf\tWhy it\u2019s challenging to demonstrate substantial equivalence.\n\u25cf\tMike\u2019s approach to evaluating and demonstrating substantial equivalence.\n\u25cf\tSome of the common errors that Mike sees in submissions that pertain to substantial equivalence.\n\u25cf\tWhat happens if you get it wrong in the eyes of the FDA.\n\u25cf\tAn explanation of product codes and how they relate to substantial equivalence.\n\u25cf\tExamples of how you might demonstrate substantial equivalence between common objects - stressing their similarities while de-emphasizing their differences.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/453f3409-63a7-463b-9467-259621b7d20b/da92b69e-401b-46e8-befb-a008d6170410.jpg"}