Do You Have a Breakthrough or De Novo Device? Here’s an Overview of the Regulatory Pathways
Wednesday, June 15 | 2:00 pm - 2:45 pm
Product Development, Quality/Regulatory
Do You Have a Breakthrough or De Novo Device? An Overview on Regulatory Pathways
Orthopedics has seen an increase in the number of products that have followed the Breakthrough Device Designation and De Novo regulatory pathways in the last two years. These pathways recognize truly novel devices. How do you determine whether your device is truly novel? And what does the regulatory path entail? This session dives into FDA’s Breakthrough Device Designation and De Novo processes, answering questions about requirements and qualifications, preparing for and submitting applications and working with FDA. Additionally, we’ll explore strategies that might get you to market faster than these pathways.
Understand the De Novo and Breakthrough Device Designation pathways
Gain knowledge of FDA expectations
Learn strategies to determine the best path to get to market