Close
On January 7, 2024, the FDA released draft guidance focused on AI-enabled device software functions. This guidance consolidates previous recommendations regarding the necessary content for marketing applications of devices utilizing AI technology. It emphasizes the importance of transparency and good machine learning practices throughout the product lifecycle.
The guidance outlines specific recommendations for device manufacturers, including detailed descriptions of AI usage, user interfaces, and risk assessments. It also highlights the need for robust data management and validation processes to ensure the safety and effectiveness of AI-enabled devices.
• FDA's guidance aims to clarify AI device marketing application requirements.
• Emphasis on transparency and machine learning practices is central to the guidance.
AI-DSF refers to software functions that utilize AI models to perform specific tasks within devices.
Data management practices are crucial for ensuring the generalizability and bias mitigation of AI models.
Validation involves demonstrating that users can effectively interact with AI-enabled devices while meeting performance specifications.
The FDA oversees the regulation of medical devices, including those that incorporate AI technologies.
Isomorphic Labs, the AI drug discovery platform that was spun out of Google's DeepMind in 2021, has raised external capital for the first time. The $600
How to level up your teaching with AI. Discover how to use clones and GPTs in your classroom—personalized AI teaching is the future.
Trump's Third Term? AI already knows how this can be done. A study shows how OpenAI, Grok, DeepSeek & Google outline ways to dismantle U.S. democracy.
Sam Altman today revealed that OpenAI will release an open weight artificial intelligence model in the coming months. "We are excited to release a powerful new open-weight language model with reasoning in the coming months," Altman wrote on X.
Log in
Sign Up
AI Tools - Popular
AI Tools - Categories
GPTs - Categories
AI for Jobs
Key AI Highlights in this Article
Key AI Terms Mentioned in this Article
Companies Mentioned in this Article
