When: 23-25 July 2025
Where: Lincoln Plaza, 2 Lincoln Plaza, Canary Wharf, London E14 9BD

Day 1 start time: 09:00 BST | Day 3 end time: 16:30 BSTThis course is also available to attend online.

 

Suitable for

This course is essential for:

• Delegates from the pharmaceutical industry who wish to develop their knowledge
• Delegates from allied industries who wish to have a comprehensive understanding of the subject
• Students on the TOPRA MSc programme.

Note: this course is also Module 21 of the MSc Regulatory Affairs.

Course information

This course will cover:

• US FD&C Act and Code of Federal Regulations
• History, Structure and Mission of the FDA
• Product Designation and Device Classification
• Pre-Submissions, Pre-Market Notification & Approval
• Combination Products
• Device Listing and Establishment Registration
• Labelling
• Quality Systems Regulation and Inspections
• Medical Device Reporting

Benefits to delegates

This course will enable you to:

• Understand the global importance of the US medical devices market and the history and context of medical device regulation in the US
• Demonstrate a critical understanding of the US medical devices regulation, processes and procedures
• Critically evaluate the different routes into the US medical device market and the regulatory requirements and processes for each
• Evaluate the differences and similarities between the regulation of medical devices in the US and EU
• Be able to make recommendations about entering the US medical devices market and a suitable strategy for doing so. This will include the ability to apply product jurisdiction, device classification criteria and identify relevant regulatory pathways and requirements
• Make sound judgments in he absence of complete data and communicate their conclusions effectively
• Critically appraise and evaluate communications relating to medical devices from US regulatory bodies and research publications

CPD: This course provides 15 CPD hours upon successful completion.
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.