{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Fe19786ff-3c54-4015-afac-f8faf594a03f","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=\"Avoiding Potential Issues with your 510(k) Submission\" frameborder=\"0\" scrolling=\"no\" allow=\"clipboard-write\" seamless src=\"http://player.captivate.fm/episode/e19786ff-3c54-4015-afac-f8faf594a03f\"></iframe>","title":"Avoiding Potential Issues with your 510(k) Submission","description":"<p>When bringing a medical device to the market, it\u2019s important to be aware of the fatal 510(k) flaw. In today\u2019s episode, Mike Drues joins the podcast to discuss the potential issues the 510(k) program presents and how companies are dealing with it.</p><p>Mike holds a Ph.D. in biomedical engineering, has served as an expert witness, and is one of the foremost regulatory minds, currently serving as the president of Vascular Sciences. Listen to today\u2019s conversation to learn how to approach a 510(k) submission if your predicate had a recall, how to develop products that are safer and more effective, and the importance of tracing the genealogy of your predicate.&nbsp;</p><h3>Some of the highlights of this episode include:</h3><ul><li>What happens when the predicate that you\u2019d like to use for your 510(k) has undergone a Class 1 recall</li><li>The risk management element of using a predicate that\u2019s undergone a Class 1 recall</li><li>The statistics about recall predicates used in 510(k)s</li><li>How the way the 510(k) is used has changed since it was first created</li><li>Why the descendants of a predicate with a Class 1 recall are so much more likely to also undergo a recall</li><li>Solving the problem of a predicate that\u2019s been through multiple recalls</li><li>Considering competitor\u2019s products or other products similar to the one yours is based on</li><li>What post-market surveillance should entail</li><li>The direct and indirect economic impact of a Class 1 recall</li><li>Changes that may happen with the FDA in the future</li></ul><h3>Memorable quotes from Mike Drues:</h3><p><em>\u201cI can tell you that of the total number of devices that come onto the market, less than 5% are Class 3s.\u201d</em></p><p><em>\u201cWhen the 510(k) was created half a century ago, it was intended to be an exception, not the rule.\u201d</em></p><p><em>\u201cI do not advocate these simple-minded solutions like no 510(k) should allow to use a predicate that\u2019s undergone a recall.\u201d</em></p><p><em>\u201cUnfortunately, good news does not sell. Bad news sells.\u201d</em></p><h3>Links:</h3><p><a href=\"https://www.linkedin.com/in/michaeldrues/\" rel=\"noopener noreferrer\" target=\"_blank\">Mike Drues</a></p><p><a href=\"https://www.vascularsci.com/\" rel=\"noopener noreferrer\" target=\"_blank\">Vascular Sciences</a></p><p><a href=\"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-based-pathway\" rel=\"noopener noreferrer\" target=\"_blank\">510(k) Guidance</a></p><p><a href=\"https://jamanetwork.com/journals/jama/article-abstract/2800188?guestAccessKey=5461ac34-d63d-40ee-93b6-ced3a1ecfafb&amp;utm_source=For_The_Media&amp;utm_medium=referral&amp;utm_campaign=ftm_links&amp;utm_content=tfl&amp;utm_term=011023\" rel=\"noopener noreferrer\" target=\"_blank\">JAMA Study 1</a></p><p><a href=\"https://jamanetwork.com/journals/jama/article-abstract/2800187\" rel=\"noopener noreferrer\" target=\"_blank\">JAMA Study 2</a></p><p><a href=\"https://www.greenlight.guru/blog/fda-510-k-submission\" rel=\"noopener noreferrer\" target=\"_blank\">FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours</a></p><p><a href=\"https://www.greenlight.guru/blog/postmarket-surveillance\" rel=\"noopener noreferrer\" target=\"_blank\">Ultimate Guide to Postmarket Surveillance of Medical Devices</a></p><p><a href=\"https://www.linkedin.com/in/etiennenichols/\" rel=\"noopener noreferrer\" target=\"_blank\">Etienne Nichols LinkedIn</a></p><p><a href=\"https://www.greenlight.guru/academy\" rel=\"noopener noreferrer\" target=\"_blank\">Greenlight Guru Academy</a></p><p><a href=\"https://www.greenlight.guru/\" rel=\"noopener noreferrer\" target=\"_blank\">Greenlight Guru</a></p><p><br></p>","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/036a0c72-279b-49f1-a0e6-508f75eda994/8b49c872-55fd-4a5f-a57d-5b6acd0e59b8.png"}