News & Analysis as of

Manufacturers Software

DLA Piper

Industrials Regulatory News and Trends - August 2024

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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

Foley & Lardner LLP

Technology Trends in Manufacturing and Associated Legal Risk Management: Driving Technological Advancement with an Ecosystem View 

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The importance of building technology-driven manufacturing businesses with an ecosystem focus—i.e., a comprehensive view of the complex network of suppliers, partners, and customers in a market—emerged as a critical theme for...more

Venable LLP

Preparing for the EU Cyber Resilience Act

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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

Robinson+Cole Data Privacy + Security Insider

CISA Alerts Manufacturers to Eliminate Default Passwords

On December 15, 2023, the Cybersecurity & Infrastructure Security Agency (CISA) issued a Secure by Design Alert and guidance on “How Manufacturers Can Protect Customers by Eliminating Default Passwords.”...more

Faegre Drinker Biddle & Reath LLP

EU Reaches Legislative Deal on Proposed ‘Digital Age’ Updates to Product Liability Directive

This week, the European Union made a significant breakthrough towards its goal of overhauling the 40-year-old Product Liability Directive for the demands of the “digital” age and modern economy. To amend the directive, the...more

Dechert LLP

Dechert Cyber Bits - Issue 43 | Key Developments in Privacy & Cybersecurity

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NSA and CISA Release Report on “Top Ten” Cybersecurity Misconfigurations; CISA Calls for Software Manufacturers to Implement Best Practices - On October 5, 2023, the United States National Security Agency (NSA) and...more

Wilson Sonsini Goodrich & Rosati

Drug Use-Related Software Back in the Spotlight at the U.S. Food and Drug Administration

In late September 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software.” This guidance expands on (and was developed in response...more

Sheppard Mullin Richter & Hampton LLP

FDA Maintains Focus on “Intended Use” for Software-Enabled Medical Devices

On June 21, 2023, the U.S. Food and Drug Administration (“FDA”) issued a warning letter to Zyto Technologies, Inc. (“Zyto”), citing Zyto’s promotion of its Hand Cradle Galvanic Skin Response (“GSR”) device and associated...more

Cozen O'Connor

The State AG Report – 7.6.2023

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Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Radio, Someone Still Loves You - •FTC Endorsement Guides...more

HaystackID

[Webcast Transcript] Best Practices for Selecting, Staffing, and Supporting Complex and High-Velocity Legal Document Reviews

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Editor’s Note: In this insightful webcast hosted by HaystackID on April 19, 2023, our expert panel delved into the best practices for selecting, staffing, and supporting complex and high-velocity legal document reviews. The...more

Goodwin

FDA Issues Draft Guidance for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions

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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

Knobbe Martens

AI & the FDA

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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

Gardner Law

The Evolving FDA Regulatory Landscape of Artificial Intelligence

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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

Ankura

Pharma Companies Can Ensure Data Integrity With User Access Management (UAM)

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Life sciences industry has regulatory compliance at the center of all its operations, so maintaining the integrity of data has always been a pressing need for this industry globally. Regulators such as the United States Food...more

Foley & Lardner LLP

Let’s Make a Deal: The American Farm Bureau Federation “Right-to-Repair” Memorandum of Understanding

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For the past several years, the “right-to-repair” movement has been at odds with many manufacturers of products (such as medical devices, motor vehicles, and equipment) that contain imbedded software and telematics used for...more

Dorsey & Whitney LLP

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

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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

Cozen O'Connor

AG Bonta Secures $25 Million Settlement with Bosch for Alleged Role in Diesel Emissions Scandal

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California AG Rob Bonta and the California Air Resources Board (CARB) have reached a settlement with German multinational engineering electronics company Robert Bosch LLC and its parent company (collectively, “Bosch”) to...more

ArentFox Schiff

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

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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

King & Spalding

FDA’s Draft Computer Software Assurance Guidance Changes the Game for Quality System and Production Software Validation

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On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer Software Assurance for...more

Seyfarth Shaw LLP

Virginia and West Virginia Adopt Laws Regulating Over-the-Air Updates

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With over-the-air (OTA) updates for motor vehicles becoming increasingly prevalent in the United States, consumers will be able to receive and install updates to vehicle firmware and software. Some updates might simply...more

MoFo Life Sciences

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

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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

MoFo Life Sciences

EU: IN VITRO Diagnostic Regulation Entered Into Force (Part 1 OF 3)

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In vitro diagnostic medical devices (IVDs), hence devices used for medical tests on samples such as blood or tissue that have been taken from the human body, have become the center of attention in the public eye during the...more

Faegre Drinker Biddle & Reath LLP

Software Liability: Why a Michigan Federal Court Decision is Relevant to Product Manufacturers Nationwide

Numerous products in our day-to-day lives incorporate or consist of software. The legal system, however, has been hesitant (at best) to bring software within traditional product liability regimes. Courts have grappled with...more

Lippes Mathias LLP

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

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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

King & Spalding

NHTSA to Require Reporting of Crashes Involving SAE Automation Levels 2+

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On June 29, 2021, the National Highway Traffic Safety Administration (NHTSA) issued a Standing General Order (SGO) to manufacturers and operators of Automated Driving Systems (ADS) and Level 2 Advanced Driver Assistance...more

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