Live! #27 — 2021 Outlook on FDA Submissions

This is the audio-only version of DEVICE LOVE Live! #27, originally recorded January 28, 2021.

We’re almost one month into 2021... and we're sure everyone's hoping for a much better year than the last! With a focus on FDA regulatory submissions, we would like to provide context for what occurred in 2020 and provide forward-looking guidance for expectations in 2021.

Will 2021 be smooth sailing or is turbulence ahead? Our panel of esteemed regulatory experts, including former FDA CDRH representatives, will discuss their thoughts on FDA focus areas, new guidance documents, and requirements on the way, along with the continued impact of COVID-19 on FDA resources and submission timelines.

Panelists:

Nancy Morrison - Executive Director, Regulatory and Quality Consulting Services Kevin Go - Senior Engineer (former FDA CDRH Lead Reviewer) Bryan Pinder - Project Engineer (former FDA CDRH Lead Reviewer) Jessica Czamanski - Project Engineer

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