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

Download the programme

Presenter

• Jonathan Hughes - Director, JHRA Ltd, UK

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

• Student: £1500 + VAT
• Delegate: £1700 + VAT

Discounted places

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.

Discounted prices

• Those working for regulatory agencies, government agencies or academic institutions: £1275 + VAT
• Those working for charities, patient groups or in full-time education: £1275 + VAT

Terms and conditions