{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Fc6575271-5fa0-4ace-944b-b83a78a0ecb7","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"What you Need to Know about FDA's Progressive Programs","description":"Are you familiar with FDA\u2019s progressive programs for medical device companies?\n\nDo you know about Expanded Access, the Expedited Access Pathway (EAP) Program, or Breakthrough Devices Program (BDP)? Jon Speer discusses these programs with Mike Drues of Vascular Sciences.\n\n\nThe FDA has created such programs to encourage companies to develop products that meet unmet clinical needs, and reduce the time and cost of bringing new or high-risk products from development to market without actually changing the approval standards.\n\nThese programs are not shortcuts and do not involve less work; it\u2019s about businesses implementing a more efficient process.\n\nSOME OF THE HIGHLIGHTS OF THE SHOW INCLUDE:\n\n\u25cf Requirement 1: Allows any device from all pathway categories, if it provides a more effective treatment/diagnosis of a life-threatening or irreversibly debilitating disease/condition.\n\n\u25cf Requirement 2: Device must represent breakthrough technology, no approved/cleared alternative exists, offers clinical meaningful advantage over existing/approved alternatives, or availability is in best interest of patients.\n\n\u25cf One advantage of BDP program is that it encourages people to come to the FDA very early during the development process; basically just need proof of concept.\n\n\u25cf A question never asked in the pre-submission is, \u201cHave we confirmed that we qualify for the BDP.\u201d Questions that were asked were technical in nature.\n\n\u25cf 2-Step Process: Take pre-submission to FDA for a BDP designation, and then submit second pre-submission that covers additional items.\n\n\u25cf Expedite access of device to market by shifting clinical data requirements from pre-market to post-market.\n\n\u25cf FDA is trying to be more progressive and innovative in giving clear and more expedited options of pathways to get medical products to market sooner.\n\n\u25cf Average regulatory professionals know the rules, the best regulatory professionals know the exceptions.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/8565e9de-da0c-4eb6-8912-35630c43d93a/e32d546e-34b5-4cd6-ad2b-13f4810d6dc9.jpg"}