Introduction to Medical Combination Products

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    "There was a lot of interaction, which was great.  I enjoyed the course director's enthusiasm and the various case studies discussed. I am not from a regulatory affairs background so it provided me with sufficient information on combination products."


    Michelle M., GxP Compliance, BioMarin

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    "Best training ever, I learned so much and it gave me a new way of thinking about regulations of combo products."


    Kristi F., Prin. RAS, Medtronic

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    "Course was exceptional compared to other regulatory courses I've taken. Great use of real world examples to demonstrate concepts."  


    Steve B. Director of R&D, DSM Biomedical

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    "The most useful part of the course was learning about new technologies and how to apply regulatory strategy.  The course was much more practical with real life examples."


    Shirley A., Senior Manager, Chugai Pharmaceutical

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Course Director

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Course Fee

$2650.00 Regular Registration

$2450.00 Early Bird Pricing (Register 30 Days in Advance)

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Future Live Stream Sessions (click to register)

Course Description

This 20-hour course covers current U.S. Food and Drug Administration (FDA) regulatory requirements for the development and marketing of combination products. From drug-eluting stents to pre-filled syringes, the landscape of combination product development is rapidly changing. The course focuses on the relevant aspects of FDA regulations and the practical steps for bringing combination products to market. We highlight several example products to provide practical, hands-on instruction.

What This Course Covers

Participants of our medical combination product regulatory strategy training will learn about:


Building a Robust Regulatory Strategy


The first part of the course provides general context for the overall topics surrounding combination products. We study the critical primary mode of action (PMOA) determination, which dictates whether your product is assigned to the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER).


Later, a more in-depth discussion on implementation within a complete combination product development environment is presented. We examine the unique challenges of FDA compliance for drug-device combination products. This includes how to navigate the 21 CFR Part 4 regulations that bridge good manufacturing practices (GMP) for both drugs and devices.


Practical Application and Compliance


FDA's regulations, guidance documents and online informational resources will be highlighted and used throughout the course. Participants will learn how to build a clear combination product development pathway that aligns with agency expectations. We will cover:


  • PMOA determination: Learn how to scientifically justify your product's primary mode of action to secure the most favorable lead center assignment. This critical decision determines whether CDER, CDRH, or CBER will lead your review, directly impacting regulatory pathways, timelines, and submission requirements.
  • Investigational applications: Discover strategies for managing investigational New Drug (IND) versus investigational device exemption (IDE) submissions. Understanding when to use each pathway helps teams avoid regulatory delays and ensure appropriate safety oversight throughout clinical development.
  • Interaction analysis: You will study drug interaction regulations for medical devices to ensure safety profiles are adequately addressed. This analysis helps identify potential risks from the interaction between device and drug components, enabling proper risk mitigation strategies and regulatory documentation.
  • Life cycle management: The course covers best practices for combination product classification and approval, including post-market safety reporting requirements. These strategies ensure ongoing compliance throughout the product lifecycle, from initial approval through manufacturing changes and adverse event reporting. 


This training has served professionals across the combination products ecosystem, from pharmaceutical innovators like BioMarin, Chugai, Astellas and Otsuka to medical device leaders like Medtronic, biomaterials specialists like DSM Biomedical and development partners like Particle Sciences, as they navigate the complex regulatory landscape where drugs and devices converge.

Who Should Attend Medical Combination Product Training?

This course will be most valuable to medical device or product professionals who need a firm understanding of how to gain FDA approval for combination products. It is geared toward personnel who are newer to the industry or need to gain perspective on how to develop a successful combination product.


Professional Roles


The following professionals will benefit from this course:


  • Engineers
  • Managers
  • Supervisors
  • Scientists
  • Technicians
  • Product development specialists
  • Manufacturing personnel
  • Quality assurance professionals
  • Regulatory affairs specialists


Applicable Industries


This training is valuable for anyone working with medical combination products in:


  • Medical device companies
  • Pharmaceutical companies
  • Biotechnology firms
  • Contract manufacturing organizations (CMOs)
  • Regulatory consulting firms


Register for Livestream Request On-Site Details

Additional Course Information


  • Learning Objectives

    Upon completion of this course, attendees will have an understanding of the framework for the specific FDA combination product regulations required to speed a product to market. The course will also provide an overview of medical device, drug and biologic product regulations to the extent that they relate to combination products. 


    Emphasis will be placed not only on the regulatory aspects of product development, but also on overall medical product strategy and the development environment. Instructional emphasis is on taking an efficient, cost-effective approach to obtaining FDA approval for your combination product, thereby avoiding unnecessary spending and wasted time.


    Exercises will reinforce the key concepts. Attendees will receive extensive course notes that can serve as reference material after the course is completed.

  • Agenda


    Context for Course and FDA's Combination Products

    • Context of combination products
    • History and reason for special treatment
    • Definitions

    Medical Device Overview

    • Regulations related to medical devices
    • Overview of medical device quality system regulations
    • Overview of medical device classifications, exemptions

    Overview of Drugs and Biologics

    • Regulations related to drugs and biologics
    • Overview of cGMP quality system regulations
    • Biologic-specific regulations

    Overview of Various Types of Medical Product Submissions

    • New drug applications (NDAs)
    • BLAs = Biologics License Applications
    • Premarket approval applications (PMAs)
    • Premarket notifications (510(k)s)
    • Medical device exemptions
    • Investigational new drug applications (INDs)
    • Investigational device exemptions (IDEs)
    • Humanitarian device exemptions (HDEs)
    • What do these mean in terms of combination products?

    Overview of Combination Products

    • Regulations related to combination products
    • Combinations that are not within the context of the regulation
    • FDA guidance documents related to combination products
    • The FDA's Office of Combination Products (OCP)

    Product Examples: Medical Devices, Drugs, Biologics and Combinations

    • Medical device examples
    • Drug examples
    • Biologic examples
    • Combination product example

    Overview of the FDA's Office of Combination Products

    • Purpose and Mission
    • Organization
    • OCP Reports
    • What can be expected from OCP
    • Statistics

    Use of Request for Designation (RFD)

    • What is a request for designation?
    • Guidance related to constructing the RFD
    • Contents of the RFD

    Using the CGMP Guidance for Combination Products

    • Introduction and background
    • Current good manufacturing practice
    • Communicating with the FDA

    Using Other General Guidance Related to Combination Products

    • Early Development Considerations for Innovative Combination Products
    • Application User Fees for Combination Products
    • Submission and Resolution of Formal Disputes Regarding Timeliness of Premarket Review of a Combination Product

    Classification and Jurisdictional Information

    • Intercenter Agreements
    • Jurisdictional Transfers
    • Jurisdictional Updates
    • RFD Jurisdictional Decisions

    Assignment Algorithm

    • Review of the assignment algorithm the agency uses for RFD
    • Examples cited by the FDA

    Wrap-up


  • Testimonials

    "This course was much more interactive and engaging than other courses I've taken.  The instructor really put us on the spot to think and contribute, thereby making me much more likely to remember the content.  The case studies brought the concepts to life."

    Gillian T., Assoc Dir Analytical Services, Particle Sciences


    "There was a lot of interaction, which was great.  I enjoyed the course director's enthusiasm and the various case studies discussed. I am not from a regulatory affairs background so it provided me with sufficient information on combination products."

    Michelle M., GxP Compliance, BioMarin


    "The most useful part of the course was learning about new technologies and how to apply regulatory strategy.  The course was much more practical with real life examples."

    Shirley A., Senior Manager, Chugai Pharmaceutical


    "This course was very well structured and taught. The instructor was eloquent, engaging, humorous and sufficiently diligent. It was one of the best courses I've taken."

    Kishan N., Manager, PCQA, Astellas


    "Best training ever, I learned so much and it gave me a new way of thinking about regulations of combo products."

    Kristi F., Prin. RAS, Medtronic


    "Absolutely, positively, the best presentation I have ever attended in 30 years of working life."

    Osman T., Associate Director, CSPV/Otsuka


    "Course was exceptional compared to other regulatory courses I've taken. Great use of real world examples to demonstrate concepts."

    Steve B. Director of R&D, DSM Biomedical


    "Better than courses I've taken with other providers. Fantastic!"

    Molly W., Senior Engineer, DSM Biomedical


Frequently Asked Questions


  • Does the Course Go Beyond Combination Product Information for the U.S. Market?

    No. The course covers the FDA's regulations, which apply only to the U.S. market.

  • What Materials Come With the Course?

    A course notebook is provided that contains the slides that are presented, publicly available reference materials from FDA and other entities, class exercises, and example documents.

  • Are There Particular Types of Combination Products Emphasized?

    The course necessarily covers a broad range of combination products. There is greater emphasis on the process related to Combination Products as compared to deeper evaluations of the specific technologies for any given product.

  • Does the Course Provide Guidance on How to Write Combination Product Applications in Order to Get to Market?

    The course does not provide an in-depth evaluation of important aspects such as style, format, level of detail and other aspects that can only come from experience gained in the medical device, drug or biologics industry(s) or potentially looking at other application examples. 


    Emphasis is placed on how the product will be regulated and on the product applications required. Further, emphasis is placed on regulations outside of product applications. One key example is how to manage a Combination Product within quality systems. Considerable emphasis is the FDA's available resources.

Registrant Information:

Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.