Exploring the Potential of Predetermined Change Control Plans (PCCP) in Medical Device Authorization

Time: 1:30 pm
day: Day Two


  • Exploring the legislation that enables companies to obtain FDA authorization for changes without requiring separate approvals
  • Seeking insights into the experiences of companies attempting to secure PCCP authorization and the potential benefits in terms of expedited modifications
  • Considering the guidance provided for AI/ML devices and exploring the broader applicability of PCCP across various types of medical devices