{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F113bce34-87e1-4bc2-8ecc-119cb8caa91c","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know","description":"What qualifies and what does not for Emergency Use Authorization (EUA)? What is the impact of this rare regulatory pathway during the COVID-19 pandemic? \n\nIn this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences in a highly relevant discussion on considerations for medical device professionals regarding EUA as a proper pathway to bring a medical device to market that can support the needs of healthcare providers and patients.\n\nSome of the highlights of the show include:\n\n- Why is it called Coronavirus? It has nothing to do with Corona beer. Rather, it comes from a family of viruses known for its crown or halo shape.\n- Similar to SARS Coronavirus that infected about 8,000 and killed about 800 people worldwide starting in 2002. Numbers for COVID-19 are much worse. \n- EUA has existed for many years and previously used primarily by drug and biotech companies for Anthrax, Ebola, H7N1, and other viruses/diseases. \n- EUA allows FDA to help strengthen the country\u2019s protection against chemical, biological, radiological, and nuclear defense threats by facilitating availability and use of medical countermeasures needed during healthcare emergencies.\n- EUA requires new or modified existing products to diagnose, treat, or prevent Coronavirus. Due to COVID-19, FDA issued as many warning letters as EUAs. \n- EUA is not an approval, clearance, or alternative to 510(k) and PMA, but temporary authorization because all EUAs will expire.\n- Political Pandemic Pressure: What would be worse\u2014not having enough ventilators, or having ventilators that don\u2019t work? Do it quickly and correctly. \n- Ventilators are not simple and ubiquitous. Review FDA product codes; prioritize list; and strive for safety and efficacy, not shortcuts to lower regulatory burden.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/c242036b-669e-4446-b8cb-0c36068da34e/23b84e9d-3c0a-4064-aa87-0bd055800f30.jpg"}