Module 9 provides an overview of international regulatory affairs with a particular focus on US FDA device regulations and path to market. The module also provides a high-level overview of the global regulatory landscape and current developments.
Learning objectives
• To develop a fundamental understanding of how to navigate through and apply the US FDA regulations governing medical devices.
• To understand the different submission document types for US market access.
• To be able to draft a Pre-submission packet and prepare for a Pre-Submission meeting.
• To have a high-level understanding of the global regulatory landscape including harmonization efforts.
• To understand the importance and applications of global regulatory intelligence.
Learning content
Module 9 covers an introduction to the US FDA regulatory infrastructure and framework, with a focus on the expectations in pre-market submissions, including the different types of medical device submission pathways. We do a deep dive into a simulated case study to learn and apply best strategies for pre-submissions and determining substantial equivalence. This module also introduces the global regulatory landscape and current developments, including practical applications and best practices.
Start & Duration
Module 9 starts in January each year.
The completion takes approximately 7 weeks.
Credits
3 ECTS
Fee
The cost of this standalone module is 3'150.– SFr.
Reference
03.009
