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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 about how medical device professionals may consider EUA as a proper pathway to bring a medical device to market that can support the needs of healthcare providers and patients.

 

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Some highlights of this episode 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.

 

Links:

Emergency Use Authorization (EUA)

Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19) 

Priority Reviews for Class III Devices Increase Likelihood of Recalls, Study Finds

Centers for Disease Control (CDC): Coronavirus (COVID-19)

Severe Acute Respiratory Syndrome (SARS)

Anthrax

Ebola 

H7N1 Influenza

De Novo

Premarket Notification 510(k)

Premarket Approval (PMA)

IEC 60601

Corona Beer

Mike Drues

Vascular Sciences

How Can Medical Device Companies Use The Emergency Use Authorization (EUA) To Address The COVID-19 Pandemic?

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru

 

Memorable Quotes by Mike Drues:

“There is no such thing as a Coronavirus. Corona refers to a family of viruses...based on the shape (crown or halo).”

“Emergency Use Authorization allows FDA to try to help strengthen our country’s protections against chemical, biological, radiological, and nuclear defense threats.”

“FDA now has issued almost as many warning letters as Emergency Use Authorizations (as a result of COVID-19).”

“When it comes to safety and efficacy, there are no shortcuts.”


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