{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F2227c157-3d37-40bb-898b-c9e2606230ff","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=\"Common Mistakes That Can Tank Your FDA 510(k) Submission\" frameborder=\"0\" scrolling=\"no\" allow=\"clipboard-write\" seamless src=\"http://player.captivate.fm/episode/2227c157-3d37-40bb-898b-c9e2606230ff\"></iframe>","title":"Common Mistakes That Can Tank Your FDA 510(k) Submission","description":"Do you know the percentage of 510(k)s that are rejected by the FDA the first time? Shockingly, it\u2019s 75%. The vast majority are rejected for poor substantial equivalence, which, as you know, defeats the purpose of the submission in the first place. Today we\u2019re going to talk to Mike Drues, president of Vascular Sciences and regulatory guru, about some common mistakes that can sink your 510(k) submission.\n\nSome of the highlights of the show include:\n\n\u25cf\tJon\u2019s motivation for writing an article about common mistakes that sink a 510(k) clearance.\n\u25cf\tThe importance of consistency with documentation and using the checklist off of the Refuse to Accept Policy.\n\u25cf\tWhy the Refuse to Accept guidance contains some minutiae.\n\u25cf\tRecommendations on providing the required testing and following the best practices.\n\u25cf\tSuggestions on how to handle showing a long shelf life.\n\u25cf\tThoughts on why the FDA is reluctant to accept promissory notes when a submission is not complete.\n\u25cf\tThoughts on risk management and why it\u2019s an important part of a submission.\n\u25cf\tThe most important takeaways regarding the 510(k) rejection problem.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/b063f8c8-6aa3-4111-8e11-b1edc6a20b30/b1316450-4590-424e-a89b-42aa05635cfc.jpg"}