Module 21: US Regulation of Medical Devices - 7FHH1159

US Regulation of Medical Devices

Next course: November/December 2023

Gives students a comprehensive understanding of US regulatory procedures for medical devices, enabling them to make recommendations on regulatory strategy for the US market.

Overview

This module includes: the US Food, Drug and Cosmetics Act; structure and mission of the FDA; device classification in the US; pre-market notification; pre-market approval; establishment registration; device listing; quality system regulation; labelling; medical device reporting; FDA audits and enforcement; combination products; key differences from the EU system.

Comprehensive and nicely paced."

Learning outcomes

Knowledge and understanding

Successful students will typically:

• 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 US medical devices regulation, processes and procedures
• Critically evaluate the different routes into the US medical devices 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.

Skills and attributes

Successful students will typically:

• 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 the 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.

Developing a global perspective of medical device regulatory affairs? Consider:

• Module 12: Data Management and Digitalisation in Regulatory Affairs
• Module 14: Design, Development and Certification of Medical Devices
• Module 15: Clinical Evaluation of Medical Devices
• Module 16: Post-Market Surveillance and Vigilance for Medical Devices
• Module 17: Regulatory Strategy in the Post Market Phase

Expanding your options? Consider:

• Module 9: Registration of Biological, Biotechnology and Advanced Therapy Products
• Module 18: Drug-device Combinations and Other Technologies
• Module 22: Regulatory Requirements for Cell, Tissue and Gene Therapies

See the table below for the next planned dates for these modules.

Module schedule

The following table outlines the scheduling for all MSc modules through 2025.

Visit our Masterclasses page to see which modules are currently open for registration.