# EUA and the Impending Transition

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-10-26
- Length: 40m
- Episode: 286
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-26-eua-and-the-impending-transition
- Listen: https://podcast.greenlight.guru/episode/eua-and-the-impending-transition

## Summary

Kyle Rose, President of RookQS, explains the FDA's phased transition away from Emergency Use Authorizations (EUA) for medical devices, detailing the 180-day timeline and the specific compliance requirements for each phase. He highlights that many companies, including non-medical manufacturers and academic labs, entered the market during the pandemic with significant gaps in their Design History Files (DHF) and Quality Management Systems (QMS). Rose advises these companies to immediately begin preparing for traditional regulatory pathways, such as 510(k) or De Novo submissions, and to implement robust adverse event reporting and Unique Device Identification (UDI) systems before the final phase deadline.

## Chapters

- [2:04](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-26-eua-and-the-impending-transition#t=124) Introduction: Kyle Rose and RookQS
- [2:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-26-eua-and-the-impending-transition#t=154) EUA Transition Timeline and Phases
- [6:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-26-eua-and-the-impending-transition#t=390) Quality System Gaps in EUA Companies
- [10:18](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-26-eua-and-the-impending-transition#t=618) Phase 1: Adverse Event Reporting
- [16:37](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-26-eua-and-the-impending-transition#t=997) Phase 2: Registration and Notifications
- [19:15](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-26-eua-and-the-impending-transition#t=1155) Phase 3: Full Compliance and Submissions
- [24:50](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-26-eua-and-the-impending-transition#t=1490) Predicate Challenges and De Novo Pathways
- [30:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-10-26-eua-and-the-impending-transition#t=1829) QMSR and ISO 13485 Alignment

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)

## Most relevant to

early-stage companies

## Mentioned

- RookQS (company)
- Greenlight Guru (company)
- FDA (other)
- ISO 13485 (other)
- 510(k) (other)
- De Novo (other)
- UDI (other)

## Related episodes from other shows

- [031 - "The Five Stages Of Regulatory Grief" with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott) (Let's Combinate)
- [198 - QMSR Explained, ISO 13485 Compared, and 5 Key Things You Might’ve Missed](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-23-198-qmsr-explained-iso-13485-compared-and-5-key-things-you-mightve-missed) (Let's Combinate)
- [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)
- [106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-24-106-foia-fda-modernizing-510-k-program-de-novo-submissions-and-more-databases-wi) (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)

## 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/2022-10-26-eua-and-the-impending-transition. 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.