Pre-Conference Regulatory Tutorial Seminar at the
CIMIT Innovation Congress 2008:

The Challenge and Promise of Combination Products (Drug/Device/Biologic)

Presenters: John J. Smith, M.D., J.D. and Jennifer A. Henderson, J.D.
Hogan & Hartson LLP

Overview

Medical products that combine device technology with drugs or biologics are at the cutting edge of medical technology development.  The stuff of science fiction not so many years ago, combination products such as drug-eluting coronary stents are routinely improving outcomes for hundreds of thousands of patients, while artificial organs, advanced implantable drug-delivery systems and other combination technologies hold the promise of continued future improvements. 

While combination medical product technology moves quickly into the future, the Food and Drug Administration’s fundament regulation of these products is decades old and based on clear distinctions between device, drug and biologics-based technology.  Participants in this tutorial will learn how FDA approaches combination products and how to navigate this complex area of medical product regulation, all with a focus on moving combination medical technologies to market. 

Suggested participants from industry and academia include: 

• Senior management
• Research and development leadership
• In-house counsel and other attorneys who address clinical research and medical device issues
• Regulatory affairs professionals
• Clinical investigators 

Specific Tutorial Topics

FDA’s Regulatory Paradigm for Combination Products (Dr. Smith)

• FDA’s historic treatment of medical products
• Current approaches to combination products
• Determining a product’s “primary mode of action”
• Type of combination product reviews and their implications
• Primary center with a consultative review
• Primary center with a collaborative review
• Strategies for approaching FDA with a combination product

Interacting with FDA on Combination Products (Ms. Henderson)

• Informal communications
• The Request for Designation (RFD)
• Pre-IDE/pre-IND meetings
• Appeals and related consideration.