# Tips for Being Prepared Post-EUA (Emergency Use Authorization)

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-01-12
- Length: 41m
- Episode: 242
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-12-tips-for-being-prepared-post-eua-emergency-use-authorization
- Listen: https://podcast.greenlight.guru/episode/tips-for-being-prepared-post-eua-emergency-use-authorization

## Summary

Mike Drues of Vascular Sciences joins host Jon Speer to discuss the transition plans for medical devices currently on the market under Emergency Use Authorization (EUA). They explain that EUAs are temporary authorizations with lower regulatory and quality burdens than traditional pathways like 510(k) or De Novo, and warn that companies relying solely on EUA data will likely fail to meet the higher standards required for permanent clearance. Drues advises firms to proactively conduct gap analyses and engage in pre-submissions rather than waiting for FDA termination notices, emphasizing that EUA products must be integrated into a broader long-term regulatory strategy.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-12-tips-for-being-prepared-post-eua-emergency-use-authorization#t=0) Introduction and EUA Overview
- [2:49](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-12-tips-for-being-prepared-post-eua-emergency-use-authorization#t=169) The Nature of EUA vs. Traditional Pathways
- [10:36](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-12-tips-for-being-prepared-post-eua-emergency-use-authorization#t=636) Timeline and Termination of EUAs
- [21:43](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-12-tips-for-being-prepared-post-eua-emergency-use-authorization#t=1303) Regulatory Burden and Quality Waivers
- [29:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-01-12-tips-for-being-prepared-post-eua-emergency-use-authorization#t=1750) Strategic Transition Planning

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

companies scaling up

## Mentioned

- Vascular Sciences (company)
- Greenlight Guru (company)
- FDA (company)
- 510(k) (other)
- De Novo (other)
- PMA (other)

## Related episodes from other shows

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- [015 - "Would You Use it on a Family Member?" with Monir El Azzouzi](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-19-015-would-you-use-it-on-a-family-member-with-monir-el-azzouzi) (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)
- [069 - EU MDR Extension with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-25-069-eu-mdr-extension-with-michelle-lott) (Let's Combinate)
- [021 - "Options" with Karandeep Singh Badwal](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal) (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/2022-01-12-tips-for-being-prepared-post-eua-emergency-use-authorization. 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.