US Regulation of Medical Devices

US Regulation of Medical Devices
This Masterclass will provide you with a comprehensive understanding of the US regulatory procedures for medical devices, to enable you to make recommendations about regulatory strategy for the US market. Additionally it will provide you with an understanding of a globally important market in addition to the knowledge of the EU that the rest of the course provides.This is also Module 21 of the MSc Regulatory Affairs.

: 25–27 Sep 2019
Where: TOPRA Office, London, UK
Start Day 1: 14:00  End Day 3: 16:00

Course overview

This Masterclass will cover:

  • The US Food, Drug and Cosmetics Act
  • The structure and mission of the FDA, device classification in the US
  • Pre-market notification and approval and the establishment registration
  • Device listing
  • Quality system regulation
  • Labelling
  • Medical device reporting and combination products
  • Further information on FDA audits and enforcement and the key difference to the EU systems

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 judgements 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 19 CPD hours upon successful completion

To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.


The latest course programme is available  HERE

Module Leader

Jonathan Hughes - JHRA Ltd



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.

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


    Course fees:
    Type Student Delegate
    Standard    £1500+VAT £1700+VAT 

    Discounted places
    A limited number of discounted places are available  for those working for regulatory or government agencies, academic institutions, charities, patient groups or full time education at the rates below. 
    Please email us at for a discount code before making your booking.

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

    • VAT, if applicable, is charged at 20% 
    • The registration fee does not include accommodation 
    • Refreshments, lunch and evening meal are included in the registration fee

    Related courses:

    Module 11: The US Regulatory Environment

    Next steps

    Module 10:  Leadership and Strategic Management in Regulatory Affairs
    Module 12: Data Management and Digitalisation in Regulatory Affairs

    Terms and conditions

    Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions
    25/09/2019 - 27/09/2019
    TOPRA 6th Floor 3 Harbour Exchange London E14 9GE UNITED KINGDOM
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    Recording and photography by delegates is not permitted.