FDA Introduces New Guidance on AI for Drug Approval Submissions in 2025

New Guidance Documents:
The FDA has released two draft guidance documents on the use of artificial intelligence (AI) in medical devices and drug development, marking significant steps in clarifying regulatory approaches for AI-enabled products24.

Device AI Draft Guidance:
This guidance focuses on lifecycle management and marketing submission recommendations for AI-enabled device software functions, emphasizing a total product life cycle (TPLC) approach2.

Drug AI Draft Guidance:
This is the first FDA guidance dedicated to the use of AI in drug development, providing a seven-step, risk-based framework for establishing and assessing the credibility of AI models used to support regulatory decision-making24.

Regulatory Framework:
The FDA aims to build regulatory approaches that can be applied across different types of medical products, ensuring AI innovations comply with existing standards while fostering responsible and ethical medical product innovation35.

Increased AI Use:
There has been an uptick in AI-powered submissions for drug approvals, reflecting the growing role AI plays in drug development, prompting the need for clear regulatory guidance45.

Collaboration:
The FDA's medical product centers (CBER, CDER, CDRH, and OCP) are working together to advance the responsible use of AI in medical products, focusing on four key areas to protect public health while fostering innovation35.

Sources:

2. https://www.cov.com/news-and-insights/insights/2025/01/fda-releases-highly-anticipated-draft-guidance-documents-on-artificial-intelligence-and-devices-drugs-and-biological-products

3. https://www.ahima.org/education-events/artificial-intelligence/artificial-intelligence-regulatory-resource-guide/fda-artificial-intelligence-medical-products/

4. https://c.firstwordpharma.com/firstwordgroup/assets/images/fda6.jpg?sa=X&ved=2ahUKEwiD8OeEneaKAxUjIUQIHerMGzMQ_B16BAgFEAI

5. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/artificial-intelligence-drug-development