# Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-04-08
- Length: 45m
- Episode: 140
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-08-emergency-use-authorization-eua-101-what-medical-device-companies-need-to-know
- Listen: https://podcast.greenlight.guru/episode/emergency-use-authorization-eua-101-what-medical-device-companies-need-to-know

## Summary

Mike Drues of Vascular Sciences explains the regulatory framework for Emergency Use Authorization (EUA) to host Jon Speer of Greenlight Guru, emphasizing that it is a temporary pathway, not a shortcut for reduced testing. Drues details the specific criteria for EUAs, including the requirement to diagnose, treat, or prevent serious conditions when no adequate alternatives exist, and warns against the dangers of political pressure leading to ineffective devices like the 170 non-functional ventilators delivered in Los Angeles. He advises companies to prioritize safety and efficacy testing by triaging requirements based on risk, rather than treating the EUA as a way to bypass rigorous engineering standards.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-08-emergency-use-authorization-eua-101-what-medical-device-companies-need-to-know#t=0) Introduction: Mike Drues and Vascular Sciences on EUA
- [2:15](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-08-emergency-use-authorization-eua-101-what-medical-device-companies-need-to-know#t=135) Coronavirus etymology and SARS history
- [4:06](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-08-emergency-use-authorization-eua-101-what-medical-device-companies-need-to-know#t=246) EUA definition, history, and legal criteria
- [10:53](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-08-emergency-use-authorization-eua-101-what-medical-device-companies-need-to-know#t=653) Modifying existing devices vs. new products
- [15:57](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-08-emergency-use-authorization-eua-101-what-medical-device-companies-need-to-know#t=957) Ventilator requirements and political pressure
- [28:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-08-emergency-use-authorization-eua-101-what-medical-device-companies-need-to-know#t=1713) Triage strategy for testing and FDA submissions
- [34:09](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-08-emergency-use-authorization-eua-101-what-medical-device-companies-need-to-know#t=2049) Risk-based testing and lab conflicts
- [39:53](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-08-emergency-use-authorization-eua-101-what-medical-device-companies-need-to-know#t=2393) Parting thoughts: Recalls and moral obligation

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Mechanical engineering](https://hardwarepodcasts.com/topic/mechanical-engineering)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

early-stage companies

## Mentioned

- Vascular Sciences (company)
- FDA (other)
- SARS (other)
- COVID-19 (other)
- IEC 60601 (other)
- 510(k) (other)
- PMA (other)

## Related episodes from other shows

- [137 - The 3 Levels of Reliability, Fault Tree Analysis, Needle Safety, Emergency Use, and Risk Management with Capt. Alan Stevens](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-22-137-the-3-levels-of-reliability-fault-tree-analysis-needle-safety-emergency-use) (Let's Combinate)
- [147 - URRA Draft Guidance, uFMEA's, Design Validation, HF Summative, Comparative Analysis, Threshold Analysis and Compelling Technical Arguments with David Grosse-Wentrup](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-30-147-urra-draft-guidance-ufmeas-design-validation-hf-summative-comparative-analys) (Let's Combinate)
- [127 - "If we do our job, no one will know" with LeRonda Perry](https://hardwarepodcasts.com/podcast/people-of-packaging/2022-04-27-127-if-we-do-our-job-no-one-will-know-with-leronda-perry) (People of Packaging)
- [207 - What 99.999% Reliability Really Means](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-24-207-what-99-999-reliability-really-means) (Let's Combinate)
- [012 - "Asking then Seeing" with Sara Waxberg Mcnew](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-22-012-asking-then-seeing-with-sara-waxberg-mcnew) (Let's Combinate)

## 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/2020-04-08-emergency-use-authorization-eua-101-what-medical-device-companies-need-to-know. 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.