Subject to change
All times are in Eastern Time

2022 Curriculum Advisor:
Shelby Buettner, Assistant General Counsel and Compliance Officer, Becton Dickinson (BD)

Wednesday, November 30

11:00–11:05 AM
Welcome and Course Overview
Khara L. Minter, Assistant Director, Training Programs, FDLI

11:05 AM–12:00 PM
I.  Is My Digital Health Product a Medical Device Regulated by FDA?
Gbenga Awotunde, Genentech Inc.
Imein Bousnina, Associate Program Director, US Regulatory Policy, Genentech, Inc.

Not all digital health products 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. Overview of FDA
2. Definition of Medical Device
3. Agency Enforcement Discretion
4. Enforcement and Compliance

12:00–12:15 PM

12:15–1:15 PM
II.  What Regulatory Pathway Applies to My Digital Health Product? What Ae Other Relevant Considerations in Digital Health?   
Jeffrey Ballyns, Associate Director, Regulatory Policy, Becton Dickinson (BD)

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 Classifications and Pathways
2. Working with FDA
3. FDA Strategic Priorities and Programs
4. Other Considerations
5. Developments and Considerations

1:15–1:45 PM 

1:45–2:45 PM
III.  What Post-Marketing Issues Should I Be Considering?
Stephanie Philbin, Partner, Goodwin Procter LLP

Medical device manufacturers and other stakeholders involved in the distribution of these products must follow certain requirements. This section will describe the different FDA requirements that generally apply.

1. Registration and Listing
2. Modifications 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

2:45–3:00 PM

3:00–3:45 PM
IV.  What Advertising and Promotion Requirements Apply? 
Lisa M. Dwyer, Partner, King & Spalding LLP

This section will describe some of the requirements that govern advertising and promotion of digital health products.

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