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FDA Needs a New Approach to AI/ML-Enabled Medical Devices | Mintz

Retrieved on: 2024-03-12 20:52:37

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FDA Needs a New Approach to AI/ML-Enabled Medical Devices | Mintz. View article details on HISWAI: https://www.mintz.com/insights-center/viewpoints/2146/2024-03-12-fda-needs-new-approach-aiml-enabled-medical-devices

Summary

The article discusses the challenges faced by the FDA in regulating SaMD, particularly AI/ML-based medical software. Despite advancements in digital health, the FDA's cybersecurity and regulatory framework under the Federal Food, Drug, and Cosmetic Act struggles to keep pace with technological innovation.

Article found on: www.mintz.com

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