Sponsored Webcast: Effective Medical Device Pre-Sub Interactions

Sponsored by:

Congratulations – you have a new, cutting edge device. Your next steps for getting approval, clearance or clinical studies are key. Having an informal meeting with the FDA’s Pre-Sub program will help you achieve this. If you have never submitted a Pre-Sub, this webcast will teach you when it should be used, offer practical tips, highlight case studies and provide insight on how to develop an invaluable, long-term relationship with FDA personnel. You will also come away with more knowledge about general principles applicable to a variety of early regulatory agency interactions. Regulatory professionals with beginning to intermediate levels of experience are encouraged to attend.

Learning Levels: Basic & Intermediate

Learning Objectives:

Upon the webcast's conclusion, you will:

• Understand the Pre-Sub program’s purpose and mechanics
• Understand basic Pre-Sub application contents
• Understand how to get the most out of a Pre-Sub interaction
• Learn principles and effective strategies for any informal FDA meeting

Who Should Attend?

• Regulatory personnel
• Development engineers
• Program or project managers