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Machine Learning Regulatory Requirements Medical Devices

Gardner Law

AI in Healthcare: Navigating Legal, Ethical, and Regulatory Frontiers

Gardner Law on

On March 22, 2025, Gardner Law, PLLC proudly co-hosted a thought-provoking continuing legal education (CLE) event with the Mitchell Hamline School of Law Health Law Institute, titled “AI in Healthcare: Adapting to...more

Ropes & Gray LLP

Regulatory Landscape for AI-enabled MedTech in APAC

Ropes & Gray LLP on

Regulation of artificial intelligence (AI) in Asia Pacific remains nascent, mostly governed by existing regulatory frameworks designed for other technologies and products. It’s a work in progress. AI techniques – machine...more

Hogan Lovells

Life Sciences & Health Care Horizons 2025

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Our 2025 Life Sciences and Health Care Horizons edition is now live! Explore the latest global insights from the U.S., Asia-Pacific, Europe, Latin America, and the Middle East on the key issues and emerging trends shaping the...more

Hogan Lovells

AI Health Law & Policy: FDA’s rapidly evolving regulatory paradigms

Hogan Lovells on

Artificial intelligence has become one of the most transformative forces in health care, reshaping everything from drug discovery to diagnostics. For pharmaceutical and medical device companies, AI-driven solutions present...more

Gardner Law

AI Regulation and Legal Trends in the U.S and Abroad

Gardner Law on

The Evolving Role of AI/ML in Healthcare - The use of artificial intelligence/machine learning (AI/ML) in healthcare is evolving rapidly and introducing new challenges. Not only are medical devices using AI for diagnostics,...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 6, Issue 2, February 2025

Welcome to our second issue of 2025 of Decoded - our technology law insights e-newsletter. For those of you with an interest in the Corporate Transparency Act, Brienne Marco and Joe Unger report that the recent injunction...more

Mintz - Intellectual Property Viewpoints

Patenting AI/ML Life Sciences and TechBio Innovations – How Much Disclosure is Sufficient?

In recent years, the rapid advancement of artificial intelligence (AI) and machine learning (ML) technologies has sparked a wave of innovation across various sectors, particularly in life sciences. ML technologies have...more

McDermott Will & Emery

FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances

McDermott Will & Emery on

Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more

DLA Piper

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

DLA Piper on

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

Knobbe Martens

FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development

Knobbe Martens on

The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more

ArentFox Schiff

FDA Issues New Recommendations on Use of AI for Medical Devices, Drugs, and Biologics

ArentFox Schiff on

In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics,...more

MoFo Life Sciences

FDA Releases Draft Guidance on Evaluating the Risk and Credibility of AI Used in Establishing Drug and Device Safety,...

MoFo Life Sciences on

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more

DLA Piper

FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance

DLA Piper on

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products

FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s safety, effectiveness, or...more

Hogan Lovells

New guidance on AI-enabled device software functions clarifies information FDA expects in marketing applications

Hogan Lovells on

On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which...more

Hogan Lovells

FDA’s evolving regulatory framework for AI use in drug & device clinical trials and research

Hogan Lovells on

U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product...more

Faegre Drinker Biddle & Reath LLP

FDA Makes Draft Guidance Available on Lifecycle Management and Marketing Submission Recommendations for AI-Enabled Device Software...

On January 7, 2025, FDA published “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff”...more

King & Spalding

FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions

King & Spalding on

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 10, December 2024

Happy Holidays and welcome to our year-end issue of Decoded. We hope you enjoyed reading our technology law insights e-newsletter this year. We are already planning for 2025. ...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 8, October 2024

Welcome to our eighth 2024 issue of Decoded - our technology law insights e-newsletter. Thank you for reading. EU AI Act Tightens Grip on High-Risk AI Systems: Five Critical Questions for U.S. Companies - Why this is...more

King & Spalding

EU Artificial Intelligence Regulation Published - What You Need to Know

King & Spalding on

Friday, July 12, 2024, the EU published the new EU Artificial Intelligence Regulation, which is first EU AI Regulation worldwide setting requirements concerning safety and free movement of goods and services using AI...more

McDermott Will & Emery

2024 Health Report - Government Actions Affecting Food, Drug and Medical Device Industries

McDermott Will & Emery on

The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more

McDermott Will & Emery

The Impact of the New EU AI Act on the Medtech and Life Sciences Sector

McDermott Will & Emery on

As technology continues to advance almost every aspect of healthcare, so the use of AI has become an increasing focus for developers and the regulators who are racing to keep pace with rapid advancements in technology. ...more

Troutman Pepper Locke

New FDA Guidance on AI and Medical Products

Troutman Pepper Locke on

n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

Gardner Law

[Hybrid Event] MASTERING TOMORROW'S HEALTHCARE TECH: A CUTTING-EDGE APPROACH TO REGULATORY, COMPLIANCE, AND PRIVACY DEMANDS -...

Gardner Law on

FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more

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