Course overview

This Masterclass 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

Programme

You can view and download an example programme based on previous courses here

Module Leader

• Richard Vincins , Principal Strategy Consultant

Presenter

TOPRA Masterclasses are developed and delivered by a faculty of expert speakers from relevant industry, agencies, notified bodies and other stakeholders, and are validated by the University of Hertfordshire. In addition to the module leader(s) listed above, confirmed speakers for this course include:

• Richard Vincins

Suitable for

• Students of the MSc programme
• Delegates from the regulatory affairs industry who wish to develop their knowledge of the requirements of medical devices in the US market
• Delegates from allied industries who wish to have a comprehensive understanding of the subject

Pricing

Standard

Type
TOPRA MSc Student: £1650 plus VAT*
TOPRA Member: £1900 plus VAT*
Non Member: £2100 plus VAT*

* VAT, if applicable, is charged at the rate of 20%   

Discounted place

• Those working for regulatory agencies, government agencies or academic institutions
• Those working for charities, patient groups or in full-time education

A limited number of discounted places are available at the rates below. Please note that discounted places are not valid for those enrolled on the MSc course.
Please email us at meetings@topra.org for a discount code before making your booking.

Terms and conditions