{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Fbaa3a9e4-8009-4b45-bbf5-ed4610872ece","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 The FDA CDRH Experiential Learning Program","description":"FDA has a new program called, The Experiential Learning Program, which involves CDRH going to medical device companies, manufacturers, and service providers to discuss biocompatibility, in vitro diagnostics, clinical trials, and other areas.\n\nOn today\u2019s episode, Mike Drues of Vascular Sciences and Jon talk about the advantages and disadvantages of this program that encourages reviewers and companies to spend more time together.\nThe better the reviewers understand the development processes that medical devices go through, the better they can work effectively with the companies to get medical devices on the market.\n\nSOME OF THE HIGHLIGHTS OF THE SHOW INCLUDE:\n\n\u25cf Who\u2019s job is it to teach CDRH staff on how medical devices are developed?\n\u25cf When an FDA visitor is in the building, will the visit be realistic to open and honest discussion? Or filtered and sanitized?\n\u25cf Visits could work to your advantage. You can \u201ctoot your own horn\u201d as a medical device company that has a good regulatory process and sets the bar for quality.\n\u25cf Skeptics may view the program as a sneaky way for FDA to come in, inspect what\u2019s going on, and force changes - involves companies taking calculated risks.\n\u25cf CDRH wants to teach staff about certain areas. They should already have subject matter expertise, but may have never been trained.\n\u25cf CDRH should share information and experiences with medical device companies to improve collaboration without disclosing confidential details.\n\u25cf Visits offer opportunities for two types of companies: 1) device manufacturers and 2) service providers.\n\u25cf No good deed goes unpunished. So, make sure you have all your \u201cducks in a row.\u201d If you want to schedule a visit, there\u2019s a submission deadline of Sept. 26.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/12c0f681-3b2f-48fd-9fd3-733267035754/66d552bd-3b35-465e-bfd5-6199517cb5d9.jpg"}