Artificial Intelligence, Draft Guidance, Comment Period

Key Takeaways from FDA’s Draft Guidance on Use of AI in Drug and Biological Life Cycle

DLA Piper on 1/24/2025

The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. ...more

FDA Issues Draft Guidances on AI in Medical Devices, Drug Development: What Manufacturers and Sponsors Need to Know

Fenwick & West LLP on 1/15/2025

The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...more

FDA Issues Draft Guidance for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions

Goodwin on 5/2/2023

The US Food and Drug Administration (FDA or the Agency) recently issued its draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more

FDA Publishes Groundbreaking AI/ML Medical Device Draft Guidance

Nelson Mullins Riley & Scarborough LLP on 4/6/2023

The U.S. Food and Drug Administration (“FDA”) has announced its first-ever draft guidance specifically addressing the use of artificial intelligence/machine learning (“AI/ML”) in medical devices (“Draft Guidance”).This...more

NIST Seeking Comments on Draft AI Principles

Sheppard Mullin Richter & Hampton LLP on 8/25/2020

The National Institute of Standards and Technology has issue a set of draft principles for “explainable” artificial intelligence and is accepting comments until October 15, 2020. The authors of the draft principles outline...more

State Department signals increased focus on surveillance technology and human rights abuses

Hogan Lovells on 9/12/2019

On 4 September 2019 the U.S. State Department issued "Draft 'U.S. Government Guidance for the Export of Hardware, Software and Technology with Surveillance Capabilities and/or parts/know-how'" (draft guidance). ...more