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
