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Artificial Intelligence Regulatory Requirements Manufacturers

Hogan Lovells

AI Health Law & Policy: Complying with FDA GMP rules for AI-enabled diagnostic devices

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter citing a failure to obtain marketing authorization via a premarket approval (PMA) or 510(k) clearance as well as Good Manufacturing Practice (GMP)...more

Hogan Lovells

AI Health Law & Policy: Comparing regulatory landscapes for AI in medical devices in the EU and U.S.

Hogan Lovells on

Artificial intelligence is transforming the medical device industry, offering unprecedented opportunities to enhance patient care. However, this technological leap comes with significant regulatory challenges. Across the...more

BakerHostetler

[Podcast] A New World: Indemnification, Artificial Intelligence and Intellectual Property

BakerHostetler on

To describe the rise of artificial intelligence (AI) as rapid is a vast understatement. From its ubiquitous presence assisting us in our most mundane daily tasks to its warm embrace by business leaders eager to revolutionize...more

Amundsen Davis LLC

Minimizing Product Liability Risks Caused by AI: Practical Tips for Businesses

Amundsen Davis LLC on

The use of artificial intelligence AI (AI) touches many sectors in the United States, and the business world is no exception. While this exciting development has proven useful for many businesses, it is also a new source of...more

Schwabe, Williamson & Wyatt PC

[Webinar] State of Manufacturing Report Virtual Roundtable - April 2nd, 11:00 am - 12:00 pm PST

The results are in! We are excited to share the findings from our latest State of Manufacturing in the Pacific Northwest report in partnership with Aldrich CPAs + Advisors. Join our virtual roundtable to learn the key...more

American Conference Institute (ACI)

[Event] 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics and Personal Care Products - March 27th - 28th, New York,...

Attend ACI’s 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics and Personal Care Products to stay ahead of the latest environmental and sustainability developments impacting cosmetics and personal care products...more

Gardner Law

Streamlining Device Changes with Predetermined Change Control Plans (PCCPs)

Gardner Law on

In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement certain pre-approved...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

Jones Day

Radical Changes to Europe's Product Liability Rules Adopted

Jones Day on

Dramatic changes to EU product liability rules are expected to drive an increase in litigation....more

A&O Shearman

The new product liability

A&O Shearman on

On October 10, 2024, the Council of the EU adopted the new EU Directive on Liability for Defective Products, which replaces the previously applicable Product Liability Directive of 1985, thereby fundamentally changing the...more

Husch Blackwell LLP

Legal Insights for Manufacturing: Outlook for 2025

Husch Blackwell LLP on

Intensifying international crises, increasing regulatory burdens, and uncertain macroeconomic conditions have led to an era of caution for manufacturers, but hidden among those challenges are exciting opportunities for...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

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