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Artificial Intelligence/Machine Learning Medical Device Regulatory Handbook

Even before the Biden administration issued a landmark executive order on October 30, 2023, establishing new standards for artificial intelligence (AI) safety and security, the US Food and Drug Administration (FDA) had been...more

FDA’s Latest Twist on Digital Health Oversight Brings Big Shift

Facing novel, swiftly evolving technologies in the digital health space, the US Food and Drug Administration has been trying to balance fostering innovation with providing reasonable assurance of safety and effectiveness...more

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