US Regulation of Medical Technology

On completion of the three-day course delegates should be able to:

• Demonstrate a thorough understanding of US medical technology regulation by describing the principles of the regulatory system
• Devise and plan regulatory strategies to enable launch of medical technology on the US market
• Describe the alternate pathways to the US medical technology market and the associated requirements, differentiating between exempt, pre-market notification clearance and pre-market approval products
• Outline the underlying principles and regulatory processes in the US, covering FDA enforcement powers, medical device reporting, quality system regulations, establishment registrations and device listings.
• Describe the principle differences between the US and EU medical technology regulatory systems.

Topics covered by the course include:

• Introduction to US Food, Drug and Cosmetics Act
• Identify the structure and mission of FDA
• Device Classification
• Pre-market Notification
• Pre-Market Approval
• Establishment Registration
• Device listing
• Quality System Regulation and QSIT
• Labelling
• Medical Device Reporting
• FDA audits and enforcement powers
• Combination Products
• Highlight key differences to the EU system