{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F7db63c6c-c949-4a98-8a8e-01d324f511f6","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?","description":"FDA recently announced its new Safer Technologies Program (STeP), which intends to make medical devices and combination devices eligible through the Breakthrough Devices Program (BDP). \n\nRequirements for eligible devices include those that significantly improve the safety of currently available treatments or diagnostics for underlying diseases or conditions associated with less serious morbidities and mortalities. \n\nToday\u2019s guest is Mike Drues of Vascular Sciences, who joins Jon Speer to discuss how this new program may be applicable to your medical device and design efforts.\n\nSome of the highlights of the show include:\n\u25cf\tThe main difference is that STeP\u2019s focus is on improving safety; BDP\u2019s emphasis is on efficacy side of devices for more serious diseases, injuries, or conditions.\n\u25cf\tBDP vs. STeP: Which is a better option, and why? Programs should have been combined because there\u2019s a need to offer incentives for safety and effectiveness. \n\u25cf\tSTeP Eligibility Criteria: \n \u25cb\tIf device obtains BDP designation, it\u2019s not STeP eligible, and vice versa.\n \u25cb\tIf device isn\u2019t eligible for BDP, but offers significant advantage to treat and diagnose less serious diseases/conditions that meet benefit-risk profile.\n\u25cf\tSTeP mechanics eerily similar to BDP process:\n \u25cb\tPrepare pre-submission to address requirements and include abbreviated device description, data plan for clinical data, and tests to be performed.\n \u25cb\tRequest pre-submission meeting with FDA, which intends to make a determination within 60 days.\n\u25cf\tOrder of Operation: Start STeP pre-submission now or later, and then follow up with traditional submission, even if FDA doesn\u2019t approve pre-submission.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/7a69d580-2128-4003-8bf7-6d443ce0f53d/9362e7f2-eed8-44fb-861e-dead487c1cef.jpg"}