FDA Expands PCCP Guidance for AI Medical Devices

The FDA has recently announced a significant update to its guidance on Pre-Clinical Communication Plans (PCCPs) for AI medical devices. The updated guidance now allows developers to use PCCPs not only for AI-specific changes but also for any device modifications that maintain the original intended use and equivalence to the predicate. This means you can make a wider range of changes to your device without necessarily needing to conduct additional clinical studies.