Do You Have a Breakthrough or De Novo Device? Here’s an Overview of the Regulatory Pathways

When:

Wednesday, June 15 | 2:00 pm - 2:45 pm

Where:

Room 45

Level:

Novice

Intermediate

Participant Type:

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.

Learning Objectives

  • 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


Speaker

Michelle Lott

Founder and Principal,

learnRAQA