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.

 

Register

 

Industry & Firms

$499
  • +$100 for non-members
  • +$100 after 10/29/2021

Non-Profit

$399
  • +$100 for non-members
  • +$100 after 10/29/2021

Government

$399
  • +$100 for non-members
  • +$100 after 10/29/2021

Academic

$399
  • +$100 for non-members
  • +$100 after 10/29/2021

Student

$99
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To ensure that FDLI is able to provide you with a seat, materials, and meals, please register for programs at least 48 hours in advance. While onsite registration is available on a “space-available” basis; late registrants are not guaranteed materials or meals.

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.

Add This Must-Have Reference to Your Registration

Purchase A Practical Guide to FDA’s Food and Drug Law and Regulation, 7th Edition to have an overview of the key legal and regulatory topics at your fingertips. Order your copy today and it will be shipped directly to your office.

Agenda

subject to change
All times are in Eastern Daylight 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

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

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

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 

 

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.