FDA’s Rx for AI Med Devices: Clear Docs, Fair Bots, and No Bias Allowed!
FDA releases draft guidance for AI-enabled medical devices, emphasizing lifecycle approach, transparency, and bias mitigation. Public comments due April 7, 2025. Guidance Shares Strategies to Address Transparency and Bias, while Providing Key Considerations and Recommendations on Product Design, Development and Documentation FDA Drafts a Prescription for AI Med Devices: Lifecycles, Fair Bots, and Zero Bias! … Read more