Hardware Podcasts

What are the Strategic Priorities for CDRH in 2021?

Global Medical Device Podcast · 20 Jan 2021 · 46m · Episode 176

What this episode covers

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.

Most relevant to

established companies

Topics

Mentioned

Companies
Vascular Sciences, Green Light Guru, FDA, CDRH, CMS, MDIC
Also
ISO 13485

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