Module 21: US Regulation of Medical Devices

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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.

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