To describe US regulatory procedures as applied to medical technology and compare these to EU systems, so that students are capable of advising on entering the US medical technology market.
This course is also Module 7 of the MSc in Medical Technology Regulatory Affairs. Completion of the course and its associated assessments counts towards the MSc qualification.
Topics covered include:
- US Food, Drug and Cosmetics Act
- Structure and mission of FDA
- Device classification
- Pre-market notification
- Pre-market approval
- Establishment registration
- Device listing
- Quality system regulation and QSIT
- Labelling, advertising and promotion
- Medical device reporting
- FDA audits and enforcement powers
- Combination products
Three days including lectures and practical sessions
This course has been developed in partnership with TOPRA, The Organisation for Professionals in Regulatory Affairs. The course is also Module 7 of Medical Technology Regulatory Affairs MSc.