{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Ffd8300b5-c39c-4a89-9d4b-41808f562071","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"How To Avoid Major Common Mistakes During the 510(k) Process with Michael Drues","description":"We\u2019ve got a good one for you today. In episode #8 of the Global Medical Device Podcast we welcome back Michael Drues, president of Vascular Sciences. As many of our listen may recall, Mike does consulting for medical device companies, the FDA, Health Canada and other regulatory bodies.\n\nToday Jon and Mike talk about 510(k)s and some of the major mistakes some companies make when they get 510(k) clearance. Specifically, they talk about companies that get 510(k) clearance but don\u2019t have design controls, risk management and don\u2019t have a quality system.\n\nAnd it\u2019s chuck full of actionable advice and takeaways.\n\n\u201c70-75% of 510(k) and PMA submissions are rejected the first time.\u201d -Mike Drues\n\nThe FDA\u2019s mission is to make sure the products we bring to market are safe and effective. The 2 areas of 510(k) submissions that are getting the most scrutiny are the substantial equivalents argument and the risk mitigation strategy. \n\nIf you don\u2019t have a rock solid argument and a bulletproof strategy you will probably be rejected. Early and frequent communication with the FDA is the key to success. \n\n\u201cDesign controls are nothing more than a synonym for prudent engineering.\u201d - Mike Drues\n\nToday Mike and Jon talk about:\n\nWhen a 510(k) isn\u2019t necessary\nReasons for rejection of a 510(k)\n\u201cLead don\u2019t follow, tell don\u2019t ask.\u201d\nDesign controls\nMultiple Predicate Strategy / Split Predicate Strategy\nRisk Mitigation\nRegulatory checks\nCorrective Action/Preventative Action Plan\n\n\u201cPhysicians can kill patients one at a time but an FDA reviewer can kill patients thousands at a time.\u201d -Mike Drues\n\nWhat can a company do if they\u2019ve been approved for market but aren\u2019t prepared? Conduct a gap analysis, figure out what you have, figure out what\u2019s missing, fill in what\u2019s missing and be upfront about it. \n\nAsk for help if you need it. Go to the experts. There is so much more we can do to help before, rather than cleaning up problems later, but, \u201cIt\u2019s never too late to do the right thing.\u201d -Jon Speer","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/d322848a-186e-4376-8d6a-99bd8e9e06e6/9e46cde7-4e1b-41e6-9626-fcc88e56ec0c.jpg"}