US FDA Draft Guidelines to Regulate AI-Enabled Medical Devices
The US Food and Drug Administration (FDA) has taken a significant step forward in addressing the growing integration of artificial intelligence (AI) in medical device development. In its recently issued draft guidance, the FDA outlines a comprehensive framework aimed at ensuring the safety, efficacy, and reliability of AI-enabled medical devices. This move signals the agency’s commitment to fostering innovation while prioritizing patient safety and transparency. The Need for Regulatory Overs...
