FDA

The FDA app serves as a comprehensive resource for information on food, drugs, medical devices, and cosmetics. It provides access to a wide range of regulatory guidance, including updates on artificial intelligence (AI) in medical devices and drug development. Users can explore detailed guidelines on AI-enabled device software functions, which cover lifecycle management and marketing submission recommendations. The app also offers insights into the FDA's approach to AI in medical products, highlighting coordinated efforts across different FDA centers.

Key features include access to draft guidances, such as those related to AI in drug and biological products, which outline risk-based credibility assessment frameworks for AI model outputs. Additionally, users can find information on premarket pathways for medical devices, including 510(k) clearances and premarket approvals. The app is designed to support stakeholders in understanding and complying with FDA regulations, providing a valuable resource for both industry professionals and the general public interested in healthcare and consumer safety.

By using the app, users can stay informed about the latest developments in AI applications within the healthcare sector, including AI-enabled device software functions and AI's role in drug development. The app's content is structured to facilitate easy navigation and access to relevant information, making it a useful tool for anyone seeking to understand FDA policies and guidelines.