Panel Discussion Integrating Forward Development Plans (PCCP) into FDA Approval to Facilitate Growth & Iterative Design

Time: 2:00 pm
day: Conference Day Two

Details:

  • What does the “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/ Machine Learning (AI/ML)-Enabled Device Software Functions” Guidance mean?
  • Forward planning your product development to facilitate improvements and content upgrades during the approval and postapproval period
  • Incorporating long-term growth into FDA discussions and applications paving the way for future iterations of your product without requiring additional approvals

Speakers:

Randy Horton
Randy Horton
Acacia Parks
Acacia Parks