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Future PCCP Training Coming In Finalized Documents, FDA DHCoE Deputy Director Says

 
• By Hannah Daniel

The AI/ML pre-determined change control plan final guidance will include plans for agency-wide training for the implementation of PCCPs, an FDA deputy director said at the Medtech Conference.

• Source: Shutterstock

Pre-determined change control plans (PCCP) are one of the “most significant regulatory advances over the last decade,” but more training is needed to implement them consistently.

Sonja Fulmer, deputy director of the Digital Health Center of Excellence (DHCoE), told Medtech Insight during the Medtech Conference earlier this month in Anaheim, CA, that these trainings will be...

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