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