# Future of the Emergency Use Authorization (EUA): COVID, Monkeypox & Beyond

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-12-15
- Length: 43m
- Episode: 294
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-15-future-of-the-emergency-use-authorization-eua-covid-monkeypox-beyond
- Listen: https://podcast.greenlight.guru/episode/future-of-the-emergency-use-authorization-eua-covid-monkeypox-beyond

## Summary

Mike Drues, President of Vascular Sciences, discusses the evolution of Emergency Use Authorizations (EUAs) from the COVID-19 pandemic to the emerging Monkeypox health emergency. He highlights that 80% of EUA submissions during the pandemic required revisions due to poor quality and lack of experience among first-time applicants. Drues warns that companies without prior regulatory experience should seek expert help rather than expecting the FDA to guide them through the process.

## Chapters

- [0:57](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-15-future-of-the-emergency-use-authorization-eua-covid-monkeypox-beyond#t=57) Introduction and EUA Definition
- [6:40](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-15-future-of-the-emergency-use-authorization-eua-covid-monkeypox-beyond#t=400) EUA Regulatory Burden and Temporary Nature
- [15:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-15-future-of-the-emergency-use-authorization-eua-covid-monkeypox-beyond#t=933) FDA Resource Strain and Review Quality
- [17:50](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-15-future-of-the-emergency-use-authorization-eua-covid-monkeypox-beyond#t=1070) Submission Quality Statistics and Experience Gap
- [25:05](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-15-future-of-the-emergency-use-authorization-eua-covid-monkeypox-beyond#t=1505) Monkeypox EUA Developments and Future Outlook
- [34:38](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-15-future-of-the-emergency-use-authorization-eua-covid-monkeypox-beyond#t=2078) Lessons Learned and Final Takeaways

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

established companies

## Mentioned

- Vascular Sciences (company)
- Green Light Guru (company)
- FDA (company)
- HHS (company)
- CDC (company)
- 510 K (other)
- De Novo (other)
- PMA (other)

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## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-15-future-of-the-emergency-use-authorization-eua-covid-monkeypox-beyond. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.