The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI devices.

medtechdive.com

FDA aims to stem AI device bias, boost transparency in draft guidance

The FDA wants the developers of medical devices that rely on AI to disclose more detail about how their devices were developed and tested.

Ad Fontes Media

All Sides

Media Bias/Fact Check

STAT

The Boston Globe

Boston

Suffolk County

Massachusetts

United States

FDA pushes makers of AI devices to disclose more details on testing, performance

Guidance Shares Strategies to Address Transparency and Bias, while Providing Key Considerations and Recommendations on Product Design, Development and Documentation   WASHINGTON, USA – On Monday, the US Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device’s Total Product Life Cycle. The guidance, if finalized, would be …

Caribbean News Global

FDA issues comprehensive draft guidance for developers of Artificial Intelligence-Enabled Medical Devices - Caribbean News Global

The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for artificial intelligence-enabled devices. The guidance clarifies differences in terminology between the FDA and the AI device manufacturers and software developers. In addition, it provides recommendations on information needed throughout a product's life cycle for regulation of safety and efficacy.

American Hospital Association

FDA issues draft guidance on marketing submissions for AI-enabled medical devices

The US Food and Drug Administration (FDA) has issued draft guidance that includes recommendations to support development and marketing of safe and effective artificial intelligence (AI)-enabled devices.  The guidance, if finalised, would be the first guidance to provide comprehensive recommendations for AI-enabled devices throughout the total product lifecycle, providing developers an accessible set of considerations that tie together design, de…

Cardiovascular News

US FDA issues first draft guidance for AI-based medical device development - Cardiovascular News

Interventional News

US FDA issues first draft guidance for AI-based medical device development - Interventional News

Summary: The FDA released draft guidance outlining a comprehensive framework for AI-enabled devices throughout their life cycle. It details best practices in design, risk management, performance monitoring, and bias mitigation, complementing recent AI guidance. The agency seeks public feedback and will hold a webinar to discuss the proposals before finalizing them. Key Takeaways: 
The draft guidance provides structured recommendations for AI-ena…

FDA aims to stem AI device bias, boost transparency in draft guidance

Coverage Details

Bias Distribution

Ownership

Similar News Topics

Similar News Topics