News & Analysis as of August 18, 2025

Manufacturers

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A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous... more +

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

Gardner Law on 7/2/2025

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

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

Pillsbury Winthrop Shaw Pittman LLP on 4/16/2025

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

EU Adopts Cyber Resilience Act for Connected Devices

Goodwin on 10/15/2024

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

Industrials Regulatory News and Trends - August 2024

DLA Piper on 8/27/2024

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

Preparing for the EU Cyber Resilience Act

Venable LLP on 1/23/2024

The European Union (EU) is poised to enact the Cyber Resilience Act (CRA), a comprehensive cybersecurity regulation with major implications for software and connected device manufacturers in the United States and globally....more

AI & the FDA

Knobbe Martens on 4/26/2023

The use of artificial intelligence (AI) in healthcare has been growing rapidly in recent years, and AI-enabled medical devices are playing a larger role in patient care. Such devices may use machine learning algorithms to...more

The Evolving FDA Regulatory Landscape of Artificial Intelligence

Gardner Law on 3/29/2023

As artificial intelligence technology evolves on a seemingly minute-by-minute basis, the U.S. FDA’s regulatory approach continues to evolve in an effort to keep pace. “The promise of artificial intelligence in medicine is...more

Biden Administration Restricts U.S. Exports of Advanced Computing and Semiconductor Manufacturing Equipment, Software, and...

Dorsey & Whitney LLP on 11/28/2022

On October 7, 2022, the Biden Administration announced new restrictions on exports to China of advanced integrated circuits (“ICs”), computers and components containing advanced ICs, semiconductor manufacturing equipment, and...more

US Drops New Export Controls on the Chinese Semiconductor, Advanced Computing, and Supercomputer Industries

ArentFox Schiff on 10/11/2022

On Friday, October 7, 2022, the Bureau of Industry and Security (BIS) released an interim final rule containing an enormous set of export controls that will likely damage the Chinese semiconductor, advanced computing, and...more

EU: In Vitro Diagnostic Regulation Entered Into Force (Part 3 Of 3)

MoFo Life Sciences on 6/14/2022

Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition of in vitro diagnostic medical devices (IVDs), the risk-based classification system,...more

Medical Devices in the App Store? U.S. Regulation of Mobile Medical Applications

Lippes Mathias LLP on 8/23/2021

Since the start of the COVID-19 pandemic, more people than ever have downloaded and used mobile applications, or apps, to communicate with their doctors, manage prescriptions, and streamline much of the healthcare activity...more

Combatting climate change and driving digitalization without falling foul of antitrust rules

White & Case LLP on 10/9/2019

Combatting climate change and driving digital transformation of traditional industries are two key challenges of our times. Many industries are working hard to achieve the Paris Agreement climate goals, but with simultaneous...more

Are You Covered for California’s New Iot Laws?

Farella Braun + Martel LLP on 1/7/2019

In November, Tyler wrote about insurance issues raised by both the European Union’s General Data Protection Regulation (GDPR) and the California Consumer Privacy Act, which goes into effect on January 1, 2020. California’s...more

California to Regulate Security of IoT Devices

Jones Day on 10/10/2018

The Situation: California is the first state to specifically regulate the security of connective devices, which are commonly referred to as internet of things ("IoT") devices. The Result: The new law mandates that...more

Re-Thinking Supply Chain Contracts in the World of Connected Things

Foley & Lardner LLP on 2/22/2018

As the pace of innovation increases at an ever faster rate, many products that traditionally may not have been thought of as involving computers or software are incorporating these elements. In 2007, the iPhone revolutionized...more

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