{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F8e869c4e-8387-4162-b770-a788cd9ef34d","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Understanding the Difference Between a General Wellness Device and a Regulated Medical Device","description":"Today Jon Speer and Mike Drues are going to be discussing general wellness devices. Mike is the president of Vascular Sciences, and he\u2019s a guru on all things regarding compliance and medical device development. General wellness device development is relevant right now because they\u2019re so popular and widely used in today\u2019s health-conscious population. It\u2019s important to understand what a general wellness device is, when it becomes a regulated medical device, and how the two are different when it comes to FDA regulation.\n\nSome of the highlights of the show include:\n\n- The FDA\u2019s definition of a general wellness device, as well as Mike\u2019s simpler definition.\n- What makes a wellness product low-risk, and what \u201clow-risk\u201d really means when it comes to both causing harm and the potential for providing incorrect information.\n- How to know if you\u2019ve crossed a line with your wellness device and actually need to classify your product as a regulated medical device. Mike also gives examples to paint the difference more clearly.\n- How marketing a wellness device as a 510k can be beneficial for label expansion purposes, as well as how marketing it first as a wellness device can improve the 510k process -- with a caveat as to how to handle the submission.\n- The importance of prudent engineering with wellness devices; the lack of regulation is not an excuse to cut corners or take shortcuts.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/1c6069aa-05a0-4e8f-8dec-8817a4877e1d/51e891a7-cf83-4658-938a-a9c69ce0807c.jpg"}