News & Analysis as of

Software Manufacturers

Hogan Lovells

FDA finalizes cyber device “select updates” guidance, potentially affecting substantial equivalence findings for 510(k)s

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently finalized its March 2024 select updates to its guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (“Premarket...more

Gardner Law

FDA Finalizes Cybersecurity Premarket Guidance: What It Means for Medical Device Makers

Gardner Law on

The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate cybersecurity risk management into...more

Hogan Lovells

New MDCG guidance clarifies rules for medical device software available on online platforms

Hogan Lovells on

The Medical Device Coordination Group (“MDCG”) has issued guidance on the safe making available of medical device software (“MDSW”) apps on online platforms (MDCG 2025-4). MDCG 2025-4 outlines the regulatory roles of online...more

Orrick, Herrington & Sutcliffe LLP

New EU Directive Modernizes Defective Product Liability to Address New Technologies

The EU Commission has adopted Directive (EU) 2024/2853, which implements a comprehensive overhaul of the 1985 Directive 85/374/EEC on defective product liability (“New PLD”). The new framework, which complements Regulation...more

Mitratech Holdings, Inc

EU Cyber Resilience Act: How to Prepare Now

The EU Cyber Resilience Act (CRA), adopted by the European Parliament in 2024, marks a major milestone in European cybersecurity legislation. As the first EU-wide law focused on the cybersecurity of digital products, it...more

Wiley Rein LLP

GSA Announces “OneGov Strategy” to Further Administration’s Focus on Commercial Acquisitions and Consolidation of Purchasing

Wiley Rein LLP on

WHAT: On April 29, 2025, the U.S. General Services Administration (GSA) announced its OneGov Strategy for IT purchases. According to the announcement, “[t]he strategy calls for deeper, direct engagement with [Original...more

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

Faegre Drinker Biddle & Reath LLP

Ten Things to Know About the European Union’s New Product Liability Directive

After it was initially proposed more than two years ago, the European Union passed a new product liability directive (PLD) on Dec. 9, 2024, which prescribes a new legislative framework to expand and modify product liability...more

Pillsbury Winthrop Shaw Pittman LLP

The EU’s Cyber Resilience Act: New Cybersecurity Requirements for Connected Products and Software

The CRA will affect a broad range of digital products placed on the EU market (including by those based outside the EU), including connected hardware/devices, software and remote data processing solutions. The EU has adopted...more

A&O Shearman

Indirect patent infringement before the UPC: limits that manufacturers must observe in advertising and product instructions

A&O Shearman on

Ortovox Sportartikel GmbH v. Mammut Sports Group AG/GmbH (UPC_CFI_16/2024), Düsseldorf Local Division (January 14, 2025) ORD_63219/2024. Anyone developing or marketing an innovative product will want to ensure that they do...more

Goodwin

EU Updates its Product Liability Regime: Important Considerations for Providers of AI Systems and Software

Goodwin on

The European Union has significantly overhauled its product liability regime with a new directive concerning liability for defective products (Product Liability Directive). EU member states have until December 9, 2026, to...more

Warner Norcross + Judd

Lessons from CES 2025: The Legal Side of Product Innovation — What Every Manufacturer and Supplier Needs to Know

Warner Norcross + Judd on

The 2025 Consumer Electronics Show (CES) — one of the world’s most influential tech events — once again showcased groundbreaking innovations that are shaping the future of technology. I was among the over 141,000 attendees of...more

Davis Wright Tremaine LLP

Project W: Alumna Spotlight on Stephanie Benedetto

Stephanie Benedetto traces her entrepreneurial DNA to her great-grandfather, Pappy, who immigrated to the Lower East Side of Manhattan (the original garment district) from Austria in 1986. Pappy collected odds and ends of...more

Kerr Russell

Is It Really Illegal for Me to Repair My Own Machines?

Kerr Russell on

In many cases, the answer is yes, but following a recently-adopted exemption to the Digital Millennium Copyright Act (DMCA), owners of certain retail-level machines are no longer forced to hire OEM-certified technicians to...more

Fenwick & West LLP

The EU Updates its Products Liability Directive to Include AI

Fenwick & West LLP on

On Dec. 8, the European Union (EU) updated its Product Liability Directive (PLD) to, inter alia, specifically address AI software. This directive must next be “transposed,” or written into law by each of the 27 member states....more

Perkins Coie

FTC Staff Paper Finds that Most Surveyed “Smart” Products Fail to Disclose Duration of Support

Perkins Coie on

On November 26, 2024, the FTC released a staff paper regarding the disclosure of the duration of the support for the software of connected consumer devices. As the FTC staff explained, if a manufacturer stops providing...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

Troutman Pepper Locke

Consumer Advocacy Groups Urge FTC to Address Software Tethering Issues

Troutman Pepper Locke on

The Internet of Things (IoT) represents a transformative shift in how consumers interact with technology, integrating physical devices with sophisticated services to create interconnected ecosystems. As the adoption of IoT...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

DLA Piper

EU: Cyber Resilience Act published in EU Official Journal

DLA Piper on

On 20 November 2024, the EU Cyber Resilience Act (CRA) was published in the Official Journal of the EU, kicking off the phased implementation of the CRA obligations....more

Proskauer Rose LLP

EU's AI Act: Ten Facts for Organisations in the UK and US

Proskauer Rose LLP on

The EU’s AI Act (the “Act”) is the world’s first comprehensive AI law. The Act manages risks posed by certain AI systems and prohibits certain AI-related practices. UK and US organisations should not assume that the Act does...more

Goodwin

EU Adopts Cyber Resilience Act for Connected Devices

Goodwin on

On October 10, 2024, the European Council officially adopted the Cyber Resilience Act (CRA), a regulation designed to ensure that products with digital features are secure to use and resilient against cyber threats, and that...more

Holland & Knight LLP

BIS Proposes Rule to Secure Connected Vehicle Supply Chains from Foreign Adversary Threats: Rule Will Create New Compliance...

Holland & Knight LLP on

The U.S. Department of Commerce's Bureau of Industry and Security (BIS) issued a Notice of Proposed Rulemaking (Proposed Rule) on Sept. 26, 2024, to address certain undue or unacceptable risks identified in Executive Order...more

DLA Piper

Data Act Frequently Asked Questions Answered by the EU Commission

DLA Piper on

The EU Data Act is one of the cornerstones of the EU's Data Strategy and introduces a new and horizontal set of rules on data access and use to boost the EU's data economy. Most of the provisions of the Data Act will become...more

DLA Piper

Industrials Regulatory News and Trends - September 2024

DLA Piper on

Welcome to Industrials Regulatory News and Trends. In this regular bulletin, DLA Piper lawyers provide concise updates on key developments in the industrials sector to help you navigate the ever-changing business, legal, and...more

96 Results
 / 
View per page
Page: of 4

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide