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Greenlight Guru + Medical Device Entrepreneurs에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Greenlight Guru + Medical Device Entrepreneurs 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.
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Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know

45:12
 
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Manage episode 374949772 series 3504807
Greenlight Guru + Medical Device Entrepreneurs에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Greenlight Guru + Medical Device Entrepreneurs 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.
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? In 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. Some of the highlights of the show include: - 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. - 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. - EUA has existed for many years and previously used primarily by drug and biotech companies for Anthrax, Ebola, H7N1, and other viruses/diseases. - EUA allows FDA to help strengthen the country’s protection against chemical, biological, radiological, and nuclear defense threats by facilitating availability and use of medical countermeasures needed during healthcare emergencies. - 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. - EUA is not an approval, clearance, or alternative to 510(k) and PMA, but temporary authorization because all EUAs will expire. - Political Pandemic Pressure: What would be worse—not having enough ventilators, or having ventilators that don’t work? Do it quickly and correctly. - Ventilators are not simple and ubiquitous. Review FDA product codes; prioritize list; and strive for safety and efficacy, not shortcuts to lower regulatory burden.
  continue reading

350 에피소드

Artwork
icon공유
 
Manage episode 374949772 series 3504807
Greenlight Guru + Medical Device Entrepreneurs에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Greenlight Guru + Medical Device Entrepreneurs 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.
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? In 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. Some of the highlights of the show include: - 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. - 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. - EUA has existed for many years and previously used primarily by drug and biotech companies for Anthrax, Ebola, H7N1, and other viruses/diseases. - EUA allows FDA to help strengthen the country’s protection against chemical, biological, radiological, and nuclear defense threats by facilitating availability and use of medical countermeasures needed during healthcare emergencies. - 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. - EUA is not an approval, clearance, or alternative to 510(k) and PMA, but temporary authorization because all EUAs will expire. - Political Pandemic Pressure: What would be worse—not having enough ventilators, or having ventilators that don’t work? Do it quickly and correctly. - Ventilators are not simple and ubiquitous. Review FDA product codes; prioritize list; and strive for safety and efficacy, not shortcuts to lower regulatory burden.
  continue reading

350 에피소드

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