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Full Speed Ahead: FDA Final Guidance Allows Swifter Deployment of Device AI

 
• By Elizabeth Orr

The FDA’s final guidance on PCCPs for AI-driven devices highlights rapid advancements in health care AI, providing a roadmap for future progress. It emphasizes iterative improvements, version control, and maintaining device safety and effectiveness.

Cyborg running on platform
(Andrey Suslov/Shutterstock)

The US Food and Drug Administration’s final guidance on pre-determined change control plans (PCCPs) for devices using AI highlights rapid changes in health care AI since the draft was published 18 months ago and provides a roadmap for how that progress might continue.

Manufacturers can file a PCCP with their initial regulatory submission to get prior approval from the FDA on anticipated future changes to their products. The agency has detailed the potential...

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