Exploring the Potential of Predetermined Change Control Plans (PCCP) in Medical Device Authorization
Time: 2:00 pm
day: Day Two
Details:
- 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
