{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Fc649b279-a101-4609-a79e-5282dc0a8f8d","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Modernizing 510(k) Program through new FDA Safety and Performance Based Pathway","description":"FDA recently released a new guidance document titled, Safety and Performance Based Pathway, which pertains to its Premarket Notification 510(k) process. \n\nToday\u2019s guest is Mike Drues of Vascular Sciences and in this episode, Jon Speer and Mike discuss the meaning and purpose behind this new guidance. The draft version of the guidance was Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria.\n\nSome of the highlights of the show include:\n \n\u25cf\tThe guidance is part of FDA\u2019s series of transformative steps to modernize the 510(k) program and advance the review of safe and effective medical devices.\n\u25cf\tIs it possible to have a newer, more advanced technology that\u2019s safer and more effective, but also substantially equivalent?\n\u25cf\tWhat\u2019s special about the new version of the guidance? All 510(k) submissions should be safety and performance based. \n\u25cf\tFDA\u2019s new version of the guidance spins it as a sub-type of the existing Abbreviated 510(k), but limited to well-understood/established technologies. \n\u25cf\tGold standard for showing substantial equivalence is to test your device against a predicate device and compare results.\n\u25cf\tThe indication for use is important to define what is or is not a similar technology or product family.\n\u25cf\tUse new 510(k) safety and performance guidance when predicate is impractical or impossible to get. Totality of evidence is used to show substantial equivalence.\n\u25cf\tFDA tends to push 510(k) path due to familiarity over its De Novo Program that most don\u2019t understand. Instead, a catch-up version of 510(k) should be created.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/e827494a-2b82-4695-b5c5-fa545fb4cdc2/3b1253a4-be2a-43c6-93b5-bfedbf04ae63.jpg"}