{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F67e6dd4c-434d-4b26-b72b-0f42983c0971","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Explaining the Significance of Voluntary Consensus Standards","description":"What are Voluntary Consensus Standards? Why should you care about them? What role do they play in your regulatory submission process? \n\nIn this episode, Mike Drues of Vascular Sciences and I discuss the importance of such standards that affect medical device professionals.\n\nSome of the highlights of the show include:\n \n\u25cf\tGuidance and regulation are voluntary. You can comply or not. If something doesn\u2019t make sense, justify why and describe what you plan to do instead.\n\u25cf\tFDA\u2019s guidance document provides information on what standards it will accept and recognize. FDA doesn\u2019t recognize all recognized standards.\n\u25cf\tThere\u2019s a correlation between consensus standards and regulatory pathways. The abbreviated 510(k) is the most important pathway for standards.\n\u25cf\tDeclaration of Conformity: Provide proof/objective evidence. Companies need to have data/information available, but don\u2019t need to include it in a submission.\n\u25cf\tDon\u2019t assume that FDA reviewers are experts in your technology or standard. A company needs to be the expert that makes FDA reviewer\u2019s job easier.\n\u25cf\tStandards are not hoops that you have to jump through. They can offer significant, strategic, or competitive advantages. \n\u25cf\tStandards that promote the safety and efficacy of your product should be followed, but many are becoming too complicated and don\u2019t make sense.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/948f9158-e8a6-4a44-a9c3-709b812a6ac4/93f5dc58-3c3a-4623-a24c-3fc35d60a12a.jpg"}