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