# How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes?

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-12-09
- Length: 39m
- Episode: 171
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-09-how-will-emergency-use-authorization-eua-during-pandemic-influence-future-fda-po
- Listen: https://podcast.greenlight.guru/episode/how-will-emergency-use-authorization-eua-during-pandemic-influence-future-fda-policy-changes

## Summary

David Pudwill, Senior Director of Regulatory Affairs at ConvaTec and host of the 'Mr. Regulatory' channel, discusses how the FDA's Emergency Use Authorization (EUA) response to the pandemic is reshaping future medical device policy. Pudwill, a former FDA reviewer, predicts that lenient policies for digital health and remote clinical monitoring will likely become permanent, while the agency pushes for harmonization between US CFR Part 820 and ISO 13485 quality standards. He advises manufacturers to submit 510(k) applications early to secure priority review status before the public health emergency ends.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-09-how-will-emergency-use-authorization-eua-during-pandemic-influence-future-fda-po#t=0) Introduction: David Pudwill and Mr. Regulatory
- [6:32](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-09-how-will-emergency-use-authorization-eua-during-pandemic-influence-future-fda-po#t=392) FDA Bandwidth and Digital Health Flexibility
- [13:18](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-09-how-will-emergency-use-authorization-eua-during-pandemic-influence-future-fda-po#t=798) Remote Clinical Monitoring and Studies
- [19:35](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-09-how-will-emergency-use-authorization-eua-during-pandemic-influence-future-fda-po#t=1175) Harmonizing CFR Part 820 and ISO 13485
- [27:45](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-09-how-will-emergency-use-authorization-eua-during-pandemic-influence-future-fda-po#t=1665) Enforcement Discretion and EUA Grace Periods
- [33:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-09-how-will-emergency-use-authorization-eua-during-pandemic-influence-future-fda-po#t=2001) Submission Strategy and FDA Pre-submissions

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)

## Most relevant to

large enterprises

## Mentioned

- ConvaTec (company)
- Green Light Guru (company)
- Saint Jude Medical (company)
- FDA (company)
- ISO 13485 (other)
- CFR Part 820 (other)
- 510(k) (other)
- De Novo (other)

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- [079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-05-079-how-fda-reviews-combination-products-policy-eprs-and-harmonization-with-rumi) (Let's Combinate)
- [139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh](https://hardwarepodcasts.com/podcast/lets-combinate/2024-06-05-139-fda-platform-guidance-ema-q-a-guidance-for-drug-device-combinations-usp-and) (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)
- [094 - Connected Combination Products, Product Traceability, Regulating New Products, Pre-Determined Changes and AI/ML with Rumi Young](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-19-094-connected-combination-products-product-traceability-regulating-new-products) (Let's Combinate)
- [219 - FDA PreCheck and the Future of Inspections: PAI to Pre-Readiness](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-24-219-fda-precheck-and-the-future-of-inspections-pai-to-pre-readiness) (Let's Combinate)

## Citing this page

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