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Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know
FromGlobal Medical Device Podcast powered by Greenlight Guru
Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know
FromGlobal Medical Device Podcast powered by Greenlight Guru
ratings:
Length:
45 minutes
Released:
Apr 8, 2020
Format:
Podcast episode
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?
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.
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.
Released:
Apr 8, 2020
Format:
Podcast episode
Titles in the series (100)
How to Properly Use the FDA Pre-Submission Process and Why It's So Important with Mike Drues: In order to get your medical device to market, you will need to know about pre-submission and the pre-submission process. The FDA is trying to get the safest medical devices out there. The most common reasons that the FDA makes rejections is within t... by Global Medical Device Podcast powered by Greenlight Guru