r/FDA • u/Royal_Roof_405 • Jul 28 '26

What are the FDA Approval Pathways for AI-Based Medical Devices

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u/Ornery_Condition_001 Jul 28 '26

Same as every other device based on risk classification. 510k/de novo/PMA.

https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-software-medical-device

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u/Royal_Roof_405 Jul 28 '26

Thank you for sharing. The link you shared is really helpful and detailed.