Artificial Intelligence, Comment Period, Medical Devices

Key Takeaways from FDA’s Draft Guidance on Use of AI in Drug and Biological Life Cycle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The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025.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The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...more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 On Use Of AI/ML In Drug Development: Five Key Takeaways

MoFo Life Sciences on 5/12/2023

On Wednesday, May 10, 2023, the Food and Drug Administration (FDA) announced the publication of a new discussion paper titled “Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological...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FDA Issues Draft Guidance for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions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The US Food and Drug Administration (FDA or the Agency) recently issued its draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more

FDA Publishes Groundbreaking AI/ML Medical Device Draft Guidance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The U.S. Food and Drug Administration (“FDA”) has announced its first-ever draft guidance specifically addressing the use of artificial intelligence/machine learning (“AI/ML”) in medical devices (“Draft Guidance”).This...more

Reviewing Key Principles from FDA's Artificial Intelligence White Paper

McDermott Will & Emery on 8/28/2019

In April 2019, the US Food and Drug Administration (FDA) issued a white paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,”...more

How Smart is it for Medical Devices to Learn New Tricks? The FDA Seeks Feedback On Its Proposed Regulatory Framework for...

Cozen O'Connor on 5/29/2019

In the shadow of the FDA’s new Proposed Regulatory Framework for Modifications to AI/ML-Based Software as a Medical Device, manufacturers are left to contemplate enhanced product liability exposure. AI-powered devices ingest...more

FDA Proposes Pathway for Artificial Intelligence/Machine Learning Software

Stinson LLP on 4/11/2019

Last week, the FDA published a discussion paper outlining a proposed regulatory framework for artificial intelligence/machine learning software as a medical device (AI/ML SaMD)....more

FDA Proposes Regulatory Framework for Artificial Intelligence/Machine Learning Software as a Medical Device

King & Spalding on 4/10/2019

On April 2, 2019, the U.S. Food and Drug Administration (“FDA” or “Agency”) proposed a new regulatory framework to address the development and marketing of artificial intelligence and machine learning-based software as a...more

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