Popular, Cybersecurity, Manufacturers

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

7 Strategies to Overcome Supply Chain Disruptions: Mitigate Risk While Enhancing Resilience and Adaptability

Ankura on 10/14/2024

Supply chain disruption and persistent inflation remain critical issues in the global economy, with ongoing geopolitical tensions, the evolution of digital threats, and increasing emphasis on sustainability reshaping the...more

Recent Federal Strike Force Prosecutions Serve as Warning to U.S. Manufacturers and Other Exporters

Robinson+Cole Manufacturing Law Blog on 9/27/2024

The recent enforcement activities of the newest federal strike force serve as a warning to U.S. manufacturers and other businesses involved in the export of products that the government is doubling down on prosecuting trade...more

A New Look at an Old Hot Topic: The Internet of Things

Butler Snow LLP on 6/28/2024

In 1999, computer scientist Kevin Ashton coined the term “the Internet of Things” (“IoT”) in order to put a name to his idea of using RFID chips to track items as they moved throughout a supply chain. “Though there is no...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

FDA finalizes advice on cybersecurity info to include in device submissions

Hogan Lovells on 10/4/2023

The U.S. Food and Drug Administration (FDA) has finalized its guidance on “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which advises medical device manufacturers on...more

FDA Publishes New Guidance on Cybersecurity in Medical Devices

McGuireWoods LLP on 10/3/2023

In response to a growing number of cyberattacks in the healthcare and life sciences industries, on Sept. 27, 2023, the U.S. Food and Drug Administration (FDA) released updated guidance regarding cybersecurity safety...more

Recommendations for Managing Cybersecurity Threats in the Manufacturing Sector

Foley & Lardner LLP on 9/25/2023

In the hyper-connected era of smart manufacturing, accelerated by “Industry 4.0,” the manufacturing sector is undergoing a digital revolution. By leveraging technologies such as advanced automation, artificial intelligence,...more

Cybersecurity and Privacy Concerns in Collecting Data from EV Drivers' Devices

Baker Donelson on 7/7/2023

This is the fourth article in a series that addresses what businesses, organizations, and governmental entities should be considering as they navigate privacy and cybersecurity challenges encountered in the transition to...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

The Omnibus Appropriations Act Grants FDA Formal Authority to Require Cybersecurity Action by Medical Device Manufacturers

Faegre Drinker Biddle & Reath LLP on 2/21/2023

Cyberattacks affecting internet-connected medical devices like insulin pumps, intracardiac defibrillators, mobile cardiac telemetry, pacemakers and intrathecal pain pumps have increased in recent years. And such attacks show...more

Medical Device Cybersecurity: Are you Prepared?

Gardner Law on 2/14/2023

Medical device manufacturers form part of the first line of defense that health delivery organizations (HDOs) rely upon to manage and combat a cybersecurity attack....more

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

Gardner Law on 12/2/2022

US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

NHTSA issues updated cybersecurity best practices for the safety of modern vehicles

Hogan Lovells on 9/19/2022

The National Highway Traffic Safety Administration (“NHTSA”) recently issued updated guidance on cybersecurity best practices for motor vehicle safety. This non-binding guidance demonstrates NHTSA’s continued emphasis on...more

FDA’s New Draft Guidance on Cybersecurity

Gardner Law on 8/17/2022

The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...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

Modernization of Manufacturers: Safety and Cybersecurity Issues

Jackson Lewis P.C. on 5/12/2022

Like many other industries, manufacturing has been hit hard with labor shortages. As of April 2022, U.S. factory activity reportedly is at its slowest pace in more than 18 months. Consequently, many factories seek more...more

The Infrastructure Investment and Jobs Act: Key Takeaways for Employers

Jackson Lewis P.C. on 11/24/2021

On November 15, 2021, President Joe Biden signed the $1.2 trillion Infrastructure Investment and Jobs Act (IIJA) into law. According to the White House, the IIJA will play an important role in rebuilding and improving roads,...more

Regulating the Road to Autonomous Vehicles - Promoting future technological developments with a holistic and flexible legal...

Hogan Lovells on 11/15/2021

Technology for autonomous vehicles (AVs) will continue to rapidly evolve in the next few years. This rise in innovation is accompanied by the emergence of new mobility players (new entrants) as well as commercial and...more

Foley Weekly Automotive Report - July - 2

Foley & Lardner LLP on 7/20/2021

This report helps automotive suppliers inform their legal and operational decisions to help address challenges and opportunities. Key Developments - Production downtime during July and August has been scheduled for five GM...more

Congressional Investigations in the 117th Congress: U.S. Senate Oversight Activities Ramp Up

King & Spalding on 7/6/2021

Six months into the 117th Congress, the U.S. Senate has recently increased its oversight activities following a slow start. Since April, newly empowered Democratic Members have launched or requested more than 20 inquiries...more

Judge and Parties Wrestle With Thorny Legal Questions In Round 1 of Closing Arguments in Massachusetts Right to Repair Trial

Seyfarth Shaw LLP on 6/30/2021

On Friday, June 25, 2021, a Massachusetts federal district court held the first of two closing arguments in Alliance for Automotive Innovation v. Healey, a case involving a motor vehicle manufacturer trade association’s...more

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