Low to Moderate-Risk Devices: Weighing the Pros and Cons of 510(k) Clearance vs. De Novo Pathways

July 27, 2017 10:30am

Jeffrey Gibbs
Director
Hyman, Phelps & McNamara, PC (Washington, DC)

Christopher Mikson, M.D.
Partner
Mayer Brown (Washington, DC)

This session is a ready-to-use strategic primer covering the 510(k) clearance and de novo pathways, the key components of each one, and practical tips for successfully working through each process to get to market. The panel will discuss the current and future changes for the 510(k) process at the FDA, and when the de novo pathway is appropriate.