Panel Session: Navigating the FDA’s De Novo Program: Incorporating Best Practices from the Beginning

Monday, October 6, 2025 | 3:15–4:15 PM
Upper Level, Room 6C
The MedTech Conference Event Website

Speakers:
Josh Silverstein
Director, Regulatory Science and Policy, Philips (Moderator)

Allison Komiyama, PhD, RAC
Consultant, Bluestocking Health

Joshua Nipper, ME
Director, Division of Regulatory Programs 1, U.S. Food and Drug Administration

Laura Yecies, MBA, MS
CEO, Osteoboost Health

Cody Simmons
CEO, DermaSensor Inc.

The De Novo Program is the regulatory pathway in the United States for innovative medical technologies that present low to moderate risk to patients. First established in 1997, the De Novo Program has evolved considerably in recent years and more manufacturers are using this pathway to bring novel devices to market. While the FDA continues to authorize numerous products through the De Novo Program, the innovative nature of products eligible for De Novo presents unique challenges for industry and the FDA because there is no established regulatory precedent for the product. To navigate through these challenges, successful FDA engagement and regulatory strategy can make the difference between marketing authorization and a negative decision.

This session will explore the current and potential future state of the De Novo Program, including identification of best practices and common pitfalls to improve engagement with the FDA in advance of and during the Agency’s review of a De Novo request. The panel will culminate in an interactive question-and-answer session, which will allow participants to ask questions to the panelists.