Traveling to De Novo Land: Planning for a Successful Journey

Monday, September 12, 2022

3:30 PM – 4:30 PM MST

Location/Room: W106 A-B

Session Room Sponsored By

Learning Level Strategic

Session Leader/Speaker(s)

Lisa L. Pritchard, BSEEE

VP, Regulatory, Quality, Clinical & Engineering
DuVal & Associates, P.A.

Slides

Speaker(s)

Kathy Herzog, BSME

Regulatory Consultant
DuVal & Associates, P.A.

Speaker (Remote)(s)

Peter Yang, PhD

Food and Drug Administration

Description: The speed of medical device innovation has resulted in increased popularity of the De Novo pathway for US commercialization. This year began with implementation of new regulations for this pathway. This session will cover the statutory evolution of this program, current requirements, expectations for the submission and review process, and tips to help your De Novo journey take off and comfortably land with a successful product commercialization. Key questions that will be answered include: What is a De Novo? When should I consider a De Novo? What are the timelines and cost for a De Novo? How do I prepare a De Novo? What should I expect with the review process? and What are the business implications of a De Novo?

Learning Objectives:

Describe what types of products should go through the De Novo process.
Understand how to prepare a De Novo request.
Describe the advantages and disadvantages of the De Novo process to their business.