• stephanromeijn
• Jan. 10, 2025
• • Nice read
• • fda
  • regulation

AI-based medical devices are different from other (hardware) medical devices. The power of AI software is that it can change over time with updates as more data becomes available. Current regulatory processes usually require new approvals before an update can go live. This should change with the ‘Predetermined Change Control Plan for AI’ by the FDA.

By enabling retraining and validation within the bounds of the original intended use, this guidance supports faster improvements to AI performance and reduces the regulatory burden on both manufacturers and the FDA. Great to see the regulatory industry slowly adapting to AI innovations in healthcare!

Read full guidance document