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.
- Definition of Medical Device
- Agency Enforcement Discretion
Shelby Buettner, Principal Legal Counsel, Medtronic
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
- Device Classification and Pathways
- Working with FDA
- Agency Initiatives and Areas of Focus Involoving Digital Health Products (At a Glance)
- Other Considerations
- International Regulation
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.
- Registration and Listing
- Modification to a Device
- Labeling Requirements
- Quality System Regulation– Key Principles for Software
- Third Parties in Manufacturing and Quality Operations
- Adverse Events/ Product Problems
- Enforcement and Compliance
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.
- FDA and FTC Authority
- Fundamental Requirements
- Preapproval Communications – What Can I Say About My Product Before Clearance/Approval