In this episode, regulatory expert Monica Ferrante, VP of Regulatory and Quality at Aspire Bariatrics, talks regulatory strategy and approvals for new medical devices coming to market.
Monica and Dan discuss:
FDA risk classifications and how to steer down various regulatory pathways
How FDA is changing in recent years
Trends in regulation--are medical devices under-regulated by FDA?
Formal vs. informal pre-submission meetings with FDA
How to go about finding trustworthy regulatory support
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