Introduction to Medical Combination Products

Upon completion of this course, attendees will have an understanding of the framework for the specific FDA Combination Product regulations required to speed 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 focused on taking an efficient, cost-effective approach to obtaining FDA approval on your Combination Product, thus avoiding unnecessary spending and wasted time.

Exercises will be used to reinforce the key concepts. Attendees will receive extensive course notes that can be used as reference material once the course is completed.

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

• NDAs = New Drug Applications
• BLAs = Biologics License Applications
• PMAs = Premarket Approval Applications
• 510(k)s = Premarket Notifications
• Medical Device Exemptions
• INDs = Investigational New Drug Applications
• IDEs = Investigational Device Exemptions
• HDEs = Humanitarian Device Exemptions
• 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
• FDA's office of Combination Products

Product Examples – Medical Devices, Drugs, Biologics and Combinations

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

Overview of FDA's Office of Combination Products (OCP)

• 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 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 FDA

Wrap-up

"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

No. The course covers FDA's regulations which govern the US market only.

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.

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.

The course does not provide 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(ies) or potentially looking at other application examples. Emphasis is placed on how the product will be regulated and what product applications would be required. Further, emphasis is placed on regulations outside of product applications. One key example is how to manage a Combination Product in terms of quality systems. Considerable emphasis is FDA's available resources.