{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Fa622f99e-4494-451c-b81a-05ca6bcba1ab","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"FDA Plans to Modernize 510(k) - Is the Sky Falling?","description":"Have you heard the news? FDA caused quite a stir when it recently announced transformative changes that will modernize its 510(k) program to improve the safety and effectiveness of medical devices. \n\nBut as we all know, the more things change, the more they stay the same. If you dive deep into FDA\u2019s statement, you\u2019ll realize that there\u2019s probably not a lot that\u2019s different. In this episode, Mike Drues, of Vascular Sciences, and I offer an initial reaction to these changes.\n\nSome of the highlights of the show include:\n \n\u25cf\t10-Year Rule: Policy that a 510(k) can\u2019t use a predicate that\u2019s greater than 10 years old. \n\u25cf\tRoot cause for this policy may be due to recent news of medical devices gone bad and the challenge of predicate creep with 510(k)s. \n\u25cf\tRegulation states that to have a successful 510(k), you need a predicate; it doesn\u2019t state a limitation for the age of the predicate. \n\u25cf\tIt should be up to the medical device professional to decide which predicate would be the best to use - no matter if it\u2019s 1, 10, or 40 years old.\n\u25cf\tTwenty percent of 510(k)s reference a predicate greater than 10 years old. This is a solution for 20%, not the other 80%.\n\u25cf\tThere\u2019s been past movements for alternative and abbreviated 510(k) pathways. So, nothing really new or revolutionary with FDA\u2019s statement.\n\u25cf\tFDA wants manufacturers to develop newer and better technologies than what\u2019s currently available. But should \u201cbetter\u201d be a part of a 510(k)? It\u2019s an oxymoron.\n\u25cf\tIf new device increases or creates new risks than a predicate, can\u2019t be a 510(k) - but this is not usually enforced and de novos are sometimes pursued.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/eccb47d6-ace2-4529-a52e-539e0fd88e56/9f8a3a0c-71aa-4888-93b6-eda39473cfa5.jpg"}