Introduction to FDA Regulatory Process for EU Companies

Duration: 3 hours
20.05.2025, 03:00 - 06:00 PM Central Europe Summer Time, 09:00 - 12:00 AM US Eastern Standard Time

Speaker: Paige Sutton-Smith

Training objectives:

• Introducing the different FDA regulatory pathways for medical devices in the US
• Giving an overview of the classification process for medical devices in the US
• Discussing the requirements and timelines for each pathway


Training content:

• FDA device classification process
• Exempt devices
• 510(k) Premarket Notification pathway
• De Novo pathway
• Premarket Approval (PMA) pathway
• Humanitarian Device Exemptions (HDE)

The following topics will also be included in the training:

• Breakthrough Device Program
• Safer Technologies Program
• Q-Submissions
• Small Business Designation
• 513(g) Request for Information


Training format:

• Presentations with interactive discussions
• Group and individual exercises
• End of training assessment