Introductorycourse on Medical Device Regulation in the U.S.
The United States is one of the most important markets for medical devices worldwide. If you want to market your products in the U.S., you must have a thorough understanding of the requirements of the U.S. Food and Drug Administration (FDA). In this seminar, you will gain a practical overview of the U.S. regulatory system – from the organization of the FDA and product classification to approval procedures and product labeling (UDI).
You will learn how to correctly classify your product, which regulatory pathways (e.g., 510(k), De Novo, PMA) are relevant to you, and what formal requirements apply to registration and listing. You will also learn about the roles of the U.S. Agent and the Initial Importer, two key players for manufacturers outside the U.S.
- Content
- Organization of the FDA
- Structure, duties, and responsibilities of the agency
- Legislative and regulatory overview
- Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 CFR, Guidance Documents
- Product classification
- Basics of Class I–III classification and its significance for the approval pathway
- Product code / regulation number
- How to identify the correct product code and the appropriate regulation
- Approval procedures
- Overview of Premarket Notification 510(k), De Novo Classification, and Premarket Approval (PMA)
- Registration and Listing
- Obligations for manufacturers, U.S. agents, and importers – procedures in the FURLS system
- Unique Device Identification (UDI)
- Labeling requirements, the GUDID database, and practical examples
- U.S. Agent / Initial Importer
- Definitions, responsibilities, and regulatory interfaces
- Your Benefits
- You’ll gain an up-to-date overview of regulatory requirements and the standards of the medical technology industry.
- You’ll acquire a comprehensive foundation of knowledge to help you establish yourself in the medical device industry.
- You’ll understand the relationships and interactions between different departments and grasp the big picture.
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Professionals or career changers
- Regulatory affairs specialists
- Quality management specialists
- Employees from various departments who want to better understand the big picture and the interfaces with other departments
