{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Fa0fa1a37-9b22-4e8c-b144-89f596ee2d35","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"How to Use the Abbreviated FDA 510(k) Pathway to Your Advantage","description":"Do you know how to use the FDA\u2019s abbreviated 510(k)? Since only 2 percent of 510(k)s have gone the abbreviated path, it\u2019s likely an accurate assumption that many don\u2019t know how to use it. \n\nToday, Mike Drues, the president of Vascular Sciences, and Jon Speer are going to delve into the abbreviated 510(k) path and how it can benefit you.\n\nSome of the highlights of the show include:\n\n\u25cf\tThe three principal types of 510(k)s and how they differ from one another.\n\u25cf\tThe crux of the abbreviated 510(k) and how the documentation of substantial equivalence differs from how it\u2019s done for the other types.\n\u25cf\tThe most current statistics on how much the abbreviated 510(k) is used and Mike\u2019s thoughts on why the number has dropped.\n\u25cf\tThe review times for the abbreviated vs. the traditional 510(k).\n\u25cf\tInformation on the format and content of the abbreviated 510(k).\n\u25cf\tWhy it\u2019s important to show why the consensus standards are applicable even though the regulation doesn\u2019t require it.\n\u25cf\tWhy many 510(k) submissions are rejected.\n\u25cf\tWhat\u2019s happening on a regulatory perspective in other parts of the world as well as Mike\u2019s thoughts on alternatives to the 510(k). \n\u25cf\tThe importance of thinking outside the box when it comes to regulatory matters.\n\u25cf\tMike\u2019s best advice for those preparing to submit their documentation: Be aware of all of your options and the advantages and disadvantages of each.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/fcee4d2a-b086-4009-b181-2a11e8c3d621/12cca0b8-d855-4354-bf45-a344b7d62f5a.jpg"}