This Webinar presents a best practices approach to planning and executing a successful Pre-IDE Meeting with FDA. The speaker is a former CDRH Division of Cardiovascular Devices (DCD) Acting Deputy Director and Branch Chief who has significant insights into the critical factors which lead to a successful Pre-IDE interaction with FDA. The session will discuss and provide specific recommendations on how to prepare a high quality and focused Pre-IDE Submission followed by planning for a successful and interactive Pre-IDE Meeting with the FDA review team Areas Covered in the Seminar :

• Why a Face to Face Meeting?
• When to Meet with FDA?
• Pre-IDE Meeting -- Scheduling Timeframe.
• The Pre-IDE Process -- What it is and what it's not.
• How to Prepare a High Quality Pre-IDE Submission.
  • Important Considerations for Content
  • Meeting Agenda and Attendees
• "Questions to the FDA"
• Pre-IDE Meeting Preparation.
  • PowerPoint Presentation.
  • Rehearsal Meeting
• Pre-IDE Meeting.
  • Getting the Most out of Your Meeting
  • Negotiating Tactics
  • Meeting Closure, Minutes, & Follow-Up
• It's your meeting, so make sure that you get what need.