# 2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-01-29
- Length: 37m
- Episode: 131
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-01-29-2-key-areas-missing-from-fda-cdrhs-regulatory-science-priorities-for-2020
- Listen: https://podcast.greenlight.guru/episode/2-key-areas-missing-from-fda-cdrhs-regulatory-science-priorities-for-2020

## Summary

Mike Drues, a subject matter expert from Vascular Sciences, joins host John Speer of Greenlight Guru to analyze the FDA CDRH's 2020 regulatory science priorities. Drues highlights that while eight priorities remain consistent with previous years, critical areas like reprocessing reusable devices and human factors/usability have been dropped, likely due to a lack of recent high-profile press coverage rather than resolved industry issues. The discussion emphasizes that the report is largely non-actionable and urges the medical device industry to develop its own prioritized lists to foster proactive, substantive dialogue with the FDA rather than waiting for reactive regulatory guidance.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-01-29-2-key-areas-missing-from-fda-cdrhs-regulatory-science-priorities-for-2020#t=0) Introduction: Mike Drues and Vascular Sciences
- [2:19](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-01-29-2-key-areas-missing-from-fda-cdrhs-regulatory-science-priorities-for-2020#t=139) Historical Comparison: 2016/2017 vs 2020 Priorities
- [4:48](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-01-29-2-key-areas-missing-from-fda-cdrhs-regulatory-science-priorities-for-2020#t=288) Missing Priorities: Reprocessing and Human Factors
- [7:23](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-01-29-2-key-areas-missing-from-fda-cdrhs-regulatory-science-priorities-for-2020#t=443) Current 2020 Priorities and New Additions
- [9:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-01-29-2-key-areas-missing-from-fda-cdrhs-regulatory-science-priorities-for-2020#t=561) Biocompatibility and Real World Evidence
- [16:50](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-01-29-2-key-areas-missing-from-fda-cdrhs-regulatory-science-priorities-for-2020#t=1010) Big Data, AI, and Postmarket Surveillance
- [26:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-01-29-2-key-areas-missing-from-fda-cdrhs-regulatory-science-priorities-for-2020#t=1594) Critique of Report Actionability and Industry Response

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

early-stage companies

## Mentioned

- FDA (company)
- CDRH (other)
- Vascular Sciences (company)
- Greenlight Guru (company)
- UCLA (other)
- ISO (other)
- EU MDR (other)
- PMA (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)
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- [253 - FDA Is Making Big Changes to Its Inspection Approach](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-07-253-fda-is-making-big-changes-to-its-inspection-approach) (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/2020-01-29-2-key-areas-missing-from-fda-cdrhs-regulatory-science-priorities-for-2020. 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.