{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F255c5ff2-9cde-4749-aa72-ec18f2d03873","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"How General Wellness Devices Have Opened a Pandora's Box of Confusion","description":"Do you have a Fitbit, Apple Watch, or other general wellness device to track your activity, monitor your heart rate, lose weight, or count calories? Are these smart technologies considered medical devices, general wellness devices, or both?\n\nIn this episode, Jon Speer invites guest Mike Drues of Vascular Sciences to join the show as the two discuss the pros and cons, go-to-market pathways, and other considerations for general wellness products.\n\nSome of the highlights of the show include:\n\u25cf\tFDA does not regulate or classify general wellness devices that don\u2019t diagnose, treat, or prevent a disease, injury, or condition.\n\u25cf\tGeneral wellness devices are required to do what they claim to do through prudent engineering.\n\u25cf\tA general wellness device can still be considered a medical device, which creates confusion and false claims.\n\u25cf\tShould manufacturers take the wellness or regulated route? Try both by putting versions of the same device on the market at the same time. \n\u25cf\tDumbed-down vs. stronger labeling: If the technology and risk are the same, how can FDA treat the same device differently?\n\u25cf\tA wellness device exemption justification describes the device to explain how it meets labeling, technology, and risk requirements.\n\u25cf\tFDA does not have a wellness device database to address problems by requiring pre-submissions, registrations, notifications, or other options.\n\u25cf\tIf Mike is \u201ctoo busy\u201d to help, that\u2019s his code for, \u201cYou\u2019re not doing what you should be doing.\u201d","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/9313a789-b94b-468e-947e-d5174eb42b0c/48acb95e-d741-4c5d-8fe3-62a76f8ba66e.jpg"}