Before and especially during the COVID-19 pandemic, digital health, including software, mobile health applications, machine learning and AI, wearables, 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 whether and 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, current FDA premarket review initiatives, including the Software Pre-Certification Pilot Program, artificial intelligence/machine learning, and cybersecurity considerations. The course will then explore post-market and advertising considerations. Throughout the course there will be 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 Digital Health Technology and Regulation During COVID-19 and Beyond Conference.

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Industry & Firms

$599
  • +$100 for non-members

Non-Profit

$499
  • +$100 for non-members

Government

$499
  • +$100 for non-members

Academic

$499
  • +$100 for non-members

Student

$99
  • transcripts required
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A Valuable Reference In Your Preferred Format

Order FDLI’s A Practical Guide to FDA’s Food and Drug Law and Regulation, 7th Edition, now available in e-book and print formats, for an accessible overview to the key legal and regulatory topics.

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

Wednesday, September 9

12:00–12:15 PM
Welcome and Course Overview
Laura Brown, Director, Educational Programs, FDLI
Melissa Scales, Assistant Director, Educational Programs, FDLI

12:15–1:00 PM
I.  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. 

  1. Definition of Medical Device
  2. Agency Enforcement Discretion
  3. Case Studies/ Examples

Michele L. Buenafe, Partner, Morgan, Lewis & Bockius LLP

1:00–1:10 PM   
Post-Session Individual Q&As
The speaker from this session will be available to answer additional individual questions.

1:00–1:15 PM
Networking Break

1:15–2:15 PM
II.  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. We will also touch on FDA’s current initiatives in regulating digital health.

  1. Device Classification and Pathways
  2. Working with FDA
  3. Other Significant Considerations
  4. Current Agency Initiatives in Premarket Review of Digital Health Products (At a Glance)
  5. Case Studies/ Examples

Allison Fulton, Partner, Sheppard Mullin Richter & Hampton LLP

2:15–2:25 PM   
Post-Session Individual Q&As
The speaker from this session will be available to answer additional individual questions.

2:15–2:45 PM
Networking Break

2:45–3:45 PM
III.  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.

  1. Registration and Listing
  2. Modifications to a Legally Marketed Device
  3. Labeling Requirements
  4. Quality System Regulation: Key Principles for Software
  5. Third Parties in Manufacturing and Quality Operations
  6. Adverse Events/ Product Problems
  7. Enforcement and Compliance
  8. Case Studies/Examples

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

3:45–3:55 PM
Post-Session Individual Q&As
The speaker from this session will be available to answer additional individual questions.

3:45–4:00 PM
Networking Break

4:00–4:30 PM
IV. 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.

  1. FDA and FTC Authority
  2. Fundamental Requirements
  3. Preapproval Communications – What Can I Say About My Product Before Clearance/Approval  
  4. Case Studies 

Kellie Combs, Partner, Ropes & Gray LLP

4:30–4:40 PM  
Post-Session Individual Q&As
The speaker from this session will be available to answer additional individual questions.

4:30 PM
Course Adjournment

 

Curriculum Advisors

FDLI would like to thank the following Curriculum Advisors for their help in planning this course and for their assistance and support of FDLI’s Educational Programs:

Afia Asamoah, Head of Legal, Google Health, Google
Michele L. Buenafe, Partner, Morgan, Lewis & Bockius LLP
Shelby Buettner, Associate Chief Counsel, FDA – OC
Kellie B. Combs, Partner, Ropes & Gray LLP
Allison Fulton, Partner, Sheppard Mullin Richter & Hampton LLP
Colleen M. Heisey, Partner, Jones Day
Carmine Jabri, President, E.M.M.A. International Consulting Group, Inc.
Melanie Katrice Gross, Associate Director & Assistant General Counsel Healthcare Law Group, Genentech, Inc.
Veleka Peeples-Dyer, Partner, Baker McKenzie

Continuing Legal Education

FDLI applies for CLE credits in Ohio 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.