Digital health, including software, mobile health applications, machine learning and AI, wearable devices, and personalized medicine, have created innumerable possibilities in improving both patient health and provider efficiency. This course will explore the essentials of FDA regulation of innovative medical device technologies. After a brief foray into how these categories of products are regulated as medical devices, the course will cover the various regulatory pathway options for getting a technologically-focused product on the market, post-market and advertising considerations, and FDA requirements for software updates and the Software Pre-Certification Pilot Program. The course will provide ample time for Q&A.

This course provides a foundation for understanding the topics that will be discussed at a more advanced level during the Medical Devices: FDA Regulation in the Era of Technology and Innovation Conference.

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Academic

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To ensure that FDLI is able to provide you with a seat, materials, and meals, please register for programs at least 48 hours in advance. While onsite registration is available on a “space-available” basis; late registrants are not guaranteed materials or meals.

You can transfer your registration to another person at your organization for no cost by notifying us of the change. If you notify FDLI in writing at least five business days prior to the meeting, you can cancel your registration for a full refund (less a $75 fee). Refunds will be applied against the original form of payment.  

Our event policies are listed here. If you should have any further questions, please contact us at [email protected] or 800-956-6293.

Agenda

subject to change

Curriculum Advisors:
Kristin Davenport, Of Counsel, Covington & Burling LLP
Melanie Katrice Gross, Associate Director & Assistant General Counsel, Healthcare Law Group, Genentech, Inc.
Jeffrey Shapiro, Director, Hyman, Phelps & McNamara, PC

Wednesday, June 5

11:30 AM
Registration and Lunch

12:00 – 12:15 PM
Welcome and Course Overview

12:15 – 1:00 PM
Is My Digital Health Product a Medical Device?
Not all digital health products in the healthcare space meet the definition of a medical device. We’ll use examples to help understand the definition and how it applies to different use cases for software. 

  • Definition of Medical Device
  • Case Studies/ Examples

Jeffrey Shapiro, Director, Hyman, Phelps & McNamara, PC

1:00 – 2:15 PM
What Is the Approval Process for My Digital Health Product?
If digital health is regulated, there are two key questions: (1) which pathway applies? And (2) what data are required?  This section will show you how to think about these questions and how to obtain answers through interacting with FDA.

  • Device Classification, Pathways, and Examples
  • Modifications to a Legally Marketed Device
  • Working with FDA
  • Registration and Listing
  • Case Studies/ Examples

Kristin Davenport, Of Counsel, Covington & Burling LLP
Christina Kuhn, Senior Associate, Covington & Burling LLP

2:15 – 2:30 PM
Networking and Refreshment Break

2:30 – 3:30 PM
What Post-Marketing Issues Should I Be Considering?
Once a device is approved and ready for market, it must adhere to continuing manufacturing, reporting, inspection, and other requirements. This section will describe the different requirements that apply, utilizing practical examples and case studies.

  • Quality System Regulation: Key Principles for Software
  • Third Parties in Manufacturing and Quality Operations
  • Adverse Events/ Product Problems
  • Enforcement and Compliance
  • Case Studies/Examples

Carmine Jabri, President and CEO, E.M.M.A. International Consulting Group, Inc.

3:30 – 4:15 PM
What Advertising and Promotion Requirements Apply?
This section will cover FDA regulations concerning advertising and promotion of digital health products. Examples and case studies will clarify the requirements.

  • Scope of FDA Authority
  • Fundamental Requirements
  • Traditional and Other Forums
  • FDA Enforcement vs. Non-FDA Enforcement

Melanie Katrice Gross, Associate Director & Assistant General Counsel, Healthcare Law Group, Genentech, Inc.

4:15 PM
Course Adjournment

4:30 PM – 7:00 PM
Panel Presentation and Networking Reception

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 – 3.75 Credits
Pennsylvania – 3.5 Credits
Virginia – 4.0 Credits

Location and Overnight Accommodations

Course Location

Genentech
651 Gateway 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.