Thursday, June 6
8:15 – 8:55 AM
Registration and Continental Breakfast
Bakul Patel, Associate Director of Digital Health, CDRH, FDA
The Promise of Digital Health: How Is FDA Adapting Its Regulatory Approach to This Exploding New Technology?
This session will cover recent vast technological advancements in digital health, including incorporation of wearable technologies, robotics, and virtual reality, to name just a few. These technologies aim to dramatically improve patient care. Panelists will discuss FDA’s approach to regulating these new technologies, including the impact of the 21st Century Cures Act, 510(k) reform, combination products, and the Software Precertification Pilot Program (Pre-Cert).
Carla Cartwright, Director, Global Regulatory Policy, Johnson & Johnson and Member, FDLI Board of Directors
Christina Kuhn, Senior Associate, Covington & Burling LLP
Randall Ortman, Product Counsel, Verily Life Sciences LLC
Moderated by Ian Pearson, Associate, Jones Day
Coffee and Networking Break
11:00 AM–12:00 PM
De Novo Clearance is Increasingly Important as A Pathway to Market for New Technologies: How Is the Program Working Now, and What Does the Future Look Like?
FDA’s original device regulations were based on 1970s technology. More than 40 years later, developers are creating completely new device types that could not even have been envisioned in the 1970s. In order to reconcile these new device types with the classification regulations and the 510(k) program, sponsors are increasingly pursuing the de novo process. This panel will discuss FDA’s streamlining of the de novo process and the recently proposed de novo regulation, which, when finalized, will codify the pathway in existence since 1997. What is the process? Does it work? Is it proving a practical success in integrating new technologies? When is it most likely to be required? We will also cover FDA’s decision to leverage the de novo pathway to include the Pre-Cert program, recent de novo requests that were granted, and special controls.
Sergio de del Castillo, De Novo Program Lead, Office of Device Evaluation, CDRH
Paul Gadiock, Counsel, Wilson Sonsini Goodrich & Rosati
Ankur Kaushal, Senior Manager, Regulatory Affairs, Roche Sequencing Solutions
Moderated by Kristin Davenport, Of Counsel, Covington & Burling LLP
The Unique Regulatory, Legal, and Practical Challenges of Artificial Intelligence/Machine Learning
The ever-evolving nature of artificial intelligence/machine learning (AI/ML) offers vast opportunities in digital health care. A key regulatory challenge is that FDA normally requires premarket review of significant product modifications. One of the key features of AI/ML, however, is the potential for the software to modify its performance in the field based on real-world learning and adaptation. FDA has recently released a discussion paper that proposes a new regulatory framework to enable efficient approval of AI/ML-based software while still protecting patients. During this panel we will explain FDA’s new framework and discuss how it might work and/or be improved. We will also address other practical questions related to development of AI/ML-based software such as product liability concerns.
Alex Cadotte, Biomedical Engineer, CDRH
Carmine Jabri, President and CEO, E.M.M.A. International Consulting Group, Inc.
Ajit Narang, Senior Legal Director, Advanced Insulin Management, Medtronic
Moderated by Jeffrey Shapiro, Director, Hyman, Phelps & McNamara, PC