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US FDA and EU Regulatory Requirements Training for Combination Products

Prefilled syringes. Infusion pumps. Drug eluting stents. Inhalers. Surgical kits. These are all products that combine a medical device with a drug and / or biologic. This course provides an overview of combination products and explores the unique challenges of FDA and EU compliance for these products. Using exercises and case studies, we will explore US and EU regulatory pathways for combination devices and learn how to apply Good Manufacturing Practices (GMPs). You'll also walk away with a solid understanding of best practices for managing the product life cycle, from premarket through postmarket activities.

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Brief Overview of This EU and FDA Combination Products Regulatory Overview Class

SkillsLab Class ?

Class Content


Class Duration

5 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion


Continuing Education Units (CEUs)


* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 3 consecutive days. 

** Interested in private training for your team, virtually or in person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming Combination Products Regulatory Training Classes

SkillsLab $3295

There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!


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Register 3 people, 4th attends free!


*This offer cannot be combined with any other promotional offer(s).

Course Overview

Here's What We Cover in This Intensive Class on Regulatory and GMP Requirements for Combination Products 

Understand the unique regulatory requirements of combination devices and apply best practices throughout their life cycle.

Course Overview
SkillsLab Class

Defining Combination Products

  • Combination product terminology, definitions, and examples
  • Primary mode of action (PMOA) and its importance
  • Evolution of combination product regulatory oversight
  • Manufacturing scenarios
Exercise! Identifying Combination Products
Exercise! Manufacturing Scenarios Pros and Cons

Regulation of Combination Products in the US

  • Baseline regulatory requirements in 21 CFR Part 820, 210, 211, 4, 1271, and 600-680 FDA offices, intercenter agreements, and jurisdictional centers
  • Overview of medical device submission types - 510(k), PMA, IDE, HDE
  • Overview of drug submission types - NDA, IND, ANDA
Exercise! Submission Type Pros and Cons
Exercise! Locating US FDA Requirements

Regulation of Combination Products in the EU

  • Regulatory requirements of EMA, EU MDR, and role of the Competent Authority
  • EU MDR classification and Article 117
  • EU MDR General Safety and Performance Requirements (GSPRs)
Exercise! GSPR Requirements

Regulatory Pathways

  • Premarket pathways for combination products
  • Role of PMOA and FDA jurisdictional centers
  • Request for Designation and Pre-Request for Designation
Exercise! Regulatory Pathways

Quality Management Systems

  • Quality management system (QMS) components
  • Process approach model
  • QMS gaps when entering the combination product market

Design and Preproduction

  • Device and drug design control
  • Human factors / usability
  • Risk management (ISO 14971 and ICH Q9 overview)
Exercise! FDA Warning Letters

Good Manufacturing Practice (GMP)

  • US FDA Good Manufacturing Practices (GMPs) integrated with Quality System Regulations (QSR) 21 CFR 820 and ISO 13485
  • Device and drug requirements for process validation
  • EU GMPs
Exercise! Evidence for Called-Out Provisions


  • Technical documentation related to combination products
  • Device master files and drug master files
Exercise! Technical Documentation

Postmarket Activities

  • Postmarketing safety reporting for combination products
  • Inspections
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to

Determine types of medical device and drug / biologic combinations and the impact of performance claims.

Establish primary mode of action in determining classification of combination product and subsequent regulatory strategy.

Identify the applicable regulations, standards, strategies, and agencies involved in developing and marketing combination. products

Define quality system requirements for combination products, creating a gap-free system to address these requirements.

Identify similarities and differences between device and drug requirements during product realization and postmarket activities, using a life-cycle approach.

Who Should Attend

Who Should Attend

Quality, regulatory, and technical professionals in primarily device or pharma industries seeking to understand the integration of these sectors, as well as those currently working in combination product areas seeking to optimize best practices. 

  • Quality Professionals
  • Regulatory Professionals
  • Technical Professionals
  • Combo Products Personnel
  • Device / Pharma Personnel

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