The future is here! This conference will focus on the exciting promise of digital health and other medical device technology, and FDA’s recent regulatory initiatives to adapt to this technology. The conference will also explore topics such as human factors in digital health, cybersecurity, patient privacy and data protection, 3D printing of devices, the increasing importance of de novo clearances as a regulatory pathway, and the unique legal and practical challenges of artificial intelligence/machine learning.
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Practical Takeaways:
- Hear from FDA officials, including Bakul Patel, Associate Director of Digital Health at CDRH, on the latest FDA policy, enforcement, and initiatives
- How to avoid pitfalls that can be associated with health-oriented technological innovations
- FDA’s approach to regulating digital health products through the 21st Century Cures Act, 510(k) reform, the Office of Combination Products, and the Software Precertification Pilot Program (Pre-Cert).
- FDA’s new proposed framework for approving devices utilizing AI/machine learning, and associated legal and practical questions related to this software.
- How to take human behavior, abilities, limitations, and other user characteristics into account in risk management assessments and validation testing
Peer Interaction:
- Network with and learn from legal and regulatory experts.
Sponsorship Opportunities
Sponsorship opportunities are available. Please let us know if you would like more information.
Agenda
subject to change
Thursday, June 6
8:15 – 8:55 AM
Registration and Continental Breakfast
8:55–9:00 AM
FDLI Welcome
9:00–9:45 AM
Keynote Address
Bakul Patel, Associate Director of Digital Health, CDRH, FDA
9:45–10:45 AM
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
10:45–11:00 AM
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
12:00–1:00 PM
Networking Luncheon
1:00–2:00 PM
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
2:00–2:45 PM
How is 3D Printing Revolutionizing the Medical Device Industry?
3D printing is providing exciting technological possibilities for industry by creating the concept of personalized medical devices, models for clinical trials, and other possibilities. How is FDA’s regulation of 3D printers and printed medical devices both similar and different from that of other devices? The panel will discuss how companies can successfully navigate FDA regulation of this technology, as well as address the all‑important reimbursement issues.
Mark Levy, Partner, Eckert Seamans Cherin & Mellott, LLC
Farah Tabibkhoei, Senior Litigation Associate, Reed Smith
Richard Underwood, Manager, Exponent, Inc.
Moderated by Janet Rozovics Gotttlieb, Executive Director, Medical Communications, Allergan, Inc.
2:45–3:00 PM
Coffee and Networking Break
3:00–3:45 PM
Human Factors in Digital Health
A medical device user must be able to operate the device safely as intended. FDA requires manufacturers to consider human factors in the design of medical device software, i.e., to consider human behavior, abilities, limitations, and other user characteristics, and to include potential user hazards in risk management assessments and validation testing. What do these potential hazards entail? How can manufacturers determine these interactions? What kind of testing and clinical human factor studies does FDA require?
Kimberly Kontson, Biomedical Engineer, CDRH, FDA
Yarmela Pavlovic, Partner, Hogan Lovells US LLP
Kimberly Snyder, Senior Partner, Validant
Moderated by Karen Corallo, Of Counsel, Skadden, Arps, Slate, Meagher & Flom LLP
3:45–4:30 PM
Overcoming Potential Regulatory and Practical Pitfalls
This panel will discuss FDA requirements to protect against side effects of technological innovation, such as safeguards against cyber-attacks and hacking. We will also discuss practical considerations associated with technology, including patient data and privacy protection, reimbursement, and electronic signatures.
Michael Gaba, Partner and Vice Chair, FDA Practice Group, Polsinelli PC
Tyrone Heggins, Senior Manager Quality – Product Security, BD
Vernessa Pollard, Partner, Co-leader, FDA Practice, McDermott Will & Emery
4:30 PM
Closing Remarks and Adjournment
Planning Committee
Chair
Jeffrey Shapiro, Director, Hyman, Phelps & McNamara, PC
Members
Melissa Scales (Staff Liaison), FDLI
David Bloch, Principal Legal Counsel, Corporate Legal Regulatory, Medtronic
Kristin Davenport, Of Counsel, Covington & Burling
Paul Gadiock, Counsel, Wilson Sonsini Goodrich & Rosati
Janet Gottlieb, Executive Director, Medical Communications, Allergan
Robert Guzman, Regulatory Counsel, Thompson Hine LLP
Carmine Jabri, President and CEO, E.M.M.A. International Consulting Group, Inc.
Mark Levy, Member, Eckert Seamans Cherin & Mellott, LLC
Lance Shea, Partner, BakerHostetler
Sarah Stec, Senior Counsel, Medical Device Regulatory Law, Johnson & Johnson
Continuing Legal Education
FDLI applies for CLE credits in California, Ohio, Pennsylvania, and Virginia. These CLE approvals may also be honored by other states; please check with your bar association for guidance. The CLE credits will be posted as they are granted and you can request to be notified when approval is received.
Ohio – 5.0 Credits
Pennsylvania – 5.0 Credits
Virginia – 5.0 Credits
Location and Overnight Accommodations
Conference Location
AC Hotel San Francisco Airport/Oyster Point Waterfront
1333 Veterans Blvd.
South San Francisco, CA 94080
Overnight Accommodations
Courtyard by Marriott
Airport/Oyster Point Waterfront
1300 Veterans Boulevard, South San Francisco, CA 94080
Driving, Parking, and Public Transportation
Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.
