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 great opportunities to improve 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 Conference.

subject to change
All times are in Eastern Time

11:00–11:05 AM
Welcome and Course Overview
Laura Brown, Director, Educational Programs, FDLI

11:05 AM–12:00 PM
I.  Is My Digital Health Product a Medical Device Regulated by FDA?
Not all digital health products in the healthcare space meet the definition of a “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

Shelby Buettner, Principal Legal Counsel, Medtronic
M. Jason Brooke, Attorney &Managing Member, Brooke Consulting, LLC

A special thank you to Laura Bailis, Associate Corporate Counsel, Google, for her contributions to the content of this presentation

12:00–12:15 PM
Break

12:15–1:15 PM
II. What Regulatory Pathway Applies to My Digital Health Product? What Are Other Relevant Considerations?
If a digital health product is regulated by FDA as a “device,” there are typically two threshold questions: (1) which regulatory pathway applies? And (2) what data are required to market the product? This section will highlight important considerations to keep in mind when answering these questions

1. Device Classification and Pathways
2. Working with FDA
3. Agency Initiatives and Areas of Focus Involoving Digital Health Products (At a Glance)
4. Other Considerations
5. International Regulation

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

1:15–1:45 PM   
Break

1:45–2:45 PM
III.  What Post-Marketing Issues Should I Be Considering?
Medical device manufacturers and other stakeholders involved in the distribution of these products must follow certain requirements. This section will describe the differentFDArequirements that generally apply, utilizing practical examples and case studies.

1. Registration and Listing
2. Modification to a 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

Christine P. Bump, Principal, Penn Avenue Law & Policy

2:45–3:00 PM
Break

3:00–3:45 PM
IV. What Advertising and Promotion Requirements Apply?
This section will describe 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 

Kyle Y. Faget, Partner, Foley & Lardner LLP

FDLI would like to thank Curriculum Advisor Shelby Buettner, Principal Legal Counsel, Medtronic for her help in planning this course and for her assistance and support of FDLI’s Educational Programs.

FDLI applies for CLE credits in Ohio and Virginia. These CLE approvals also may be honored by other states. The CLE credits will be posted as they are granted and registrants can request to be notified when approval is received.