# Positive and Negative Impacts of EUA on the Medical Device Industry

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-11-12
- Length: 37m
- Episode: 167
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-11-12-positive-and-negative-impacts-of-eua-on-the-medical-device-industry
- Listen: https://podcast.greenlight.guru/episode/positive-and-negative-impacts-of-eua-on-the-medical-device-industry

## Summary

Erica Loring, a regulatory expert at Greenlight Guru, discusses the positive and negative impacts of Emergency Use Authorization (EUA) on the medical device industry with host Jon Speer. They analyze how the surge in EUA applications for PPE and IVDs strained FDA resources, leading to slower reviews for non-COVID devices and concerns about reduced review rigor. Loring highlights the risks of companies without established quality management systems (QMS) entering the market and the downstream supply chain disruptions affecting biocompatibility testing and component sourcing.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-11-12-positive-and-negative-impacts-of-eua-on-the-medical-device-industry#t=0) Introduction and EUA Overview
- [3:02](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-11-12-positive-and-negative-impacts-of-eua-on-the-medical-device-industry#t=182) FDA Resource Strain and Review Delays
- [11:24](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-11-12-positive-and-negative-impacts-of-eua-on-the-medical-device-industry#t=684) EUA vs. 510(k) Rigor and Predicate Requirements
- [15:28](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-11-12-positive-and-negative-impacts-of-eua-on-the-medical-device-industry#t=928) Risks of False Negatives and New Market Entrants
- [26:40](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-11-12-positive-and-negative-impacts-of-eua-on-the-medical-device-industry#t=1600) Supply Chain Disruptions and Testing Bottlenecks
- [31:12](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-11-12-positive-and-negative-impacts-of-eua-on-the-medical-device-industry#t=1872) Post-EUA Market Impact and Advice

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

companies scaling up

## Mentioned

- Greenlight Guru (company)
- FDA (company)
- Roche (company)
- Abbott (company)
- BD (company)
- Fisher Scientific (company)

## Related episodes from other shows

- [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)
- [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)
- [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)
- [099 - Medical Device vs. Medicinal Product Reviews in the EU, Working at MHRA, Notified Bodies, EU MDR, ICH Q6 and Writing All About It with Janine Jamieson](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-23-099-medical-device-vs-medicinal-product-reviews-in-the-eu-working-at-mhra-notifi) (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/2020-11-12-positive-and-negative-impacts-of-eua-on-the-medical-device-industry. 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.