# What are the Strategic Priorities for CDRH in 2021?

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-01-20
- Length: 46m
- Episode: 176
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-20-what-are-the-strategic-priorities-for-cdrh-in-2021
- Listen: https://podcast.greenlight.guru/episode/what-are-the-strategic-priorities-for-cdrh-in-2021

## Summary

Mike Drues from Vascular Sciences joins host John Spear to discuss the FDA’s Center for Devices and Radiological Health (CDRH) strategic priorities for 2021, noting a 'reset' of previous goals amid the pandemic. Drues highlights the significant strain on FDA resources due to over 5,000 Emergency Use Authorization (EUA) submissions, which has caused delays in non-COVID device reviews and even led to the rejection of pre-submissions due to lack of bandwidth. The conversation covers the FDA's goal for novel devices to launch in the US first or in parallel with global markets, the expansion of the 'Case for Quality' program, and the political uncertainty surrounding the incoming Biden administration's regulatory approach.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-20-what-are-the-strategic-priorities-for-cdrh-in-2021#t=0) Introduction and CDRH Strategic Priorities Overview
- [2:06](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-20-what-are-the-strategic-priorities-for-cdrh-in-2021#t=126) FDA-CMS Parallel Review and Breakthrough Device Program
- [10:20](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-20-what-are-the-strategic-priorities-for-cdrh-in-2021#t=620) Impact of COVID-19 on FDA Resources and EUA Statistics
- [17:20](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-20-what-are-the-strategic-priorities-for-cdrh-in-2021#t=1040) Delays in Non-COVID Reviews and Pre-submission Rejections
- [22:17](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-20-what-are-the-strategic-priorities-for-cdrh-in-2021#t=1337) Novel Device Launch Goals and Tracking System
- [27:43](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-20-what-are-the-strategic-priorities-for-cdrh-in-2021#t=1663) Case for Quality Expansion and Software Guidance Updates
- [33:53](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-20-what-are-the-strategic-priorities-for-cdrh-in-2021#t=2033) Political Impact of the New Administration on Regulation
- [39:59](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-20-what-are-the-strategic-priorities-for-cdrh-in-2021#t=2399) Key Takeaways and Industry Resilience

## Topics

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

## Most relevant to

established companies

## Mentioned

- Vascular Sciences (company)
- Green Light Guru (company)
- FDA (company)
- CDRH (company)
- CMS (company)
- ISO 13485 (other)
- MDIC (company)

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## 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/2021-01-20-what-are-the-strategic-priorities-for-cdrh-in-2021. 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.