News & Analysis as of August 2, 2025

Manufacturers

+ Follow

Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk... more +

Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk management, global regulations, data protection, leaks, hacking, cyber insurance, compliance, HIPAA, and every other aspect of cybersecurity of import to corporate readers right now. less -

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

Hogan Lovells on 7/7/2025

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

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

Key Messaging from ‘Aging Technology, Emerging Threats: Examining Cybersecurity Vulnerabilities in Legacy Medical Devices’

Morgan Lewis on 4/10/2025

On April 1, 2025, the subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce held a hearing on cybersecurity vulnerabilities in legacy medical devices. The hearing was largely a...more

New FDA Guidance on AI and Medical Products

Troutman Pepper Locke on 4/12/2024

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

Cybersecurity in Medical Devices

BakerHostetler on 4/10/2023

The U.S. Food and Drug Administration (FDA) has issued new guidance to the medical device industry on the importance of cybersecurity measures in product development. ...more

NHTSA Updates Cybersecurity Best Practices for the Safety of New Vehicles

Latham & Watkins LLP on 10/10/2022

The National Highway Traffic Safety Administration’s updated guidance encourages auto industry suppliers and manufacturers to consider cybersecurity a top organizational priority. On September 9, 2022, the National...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

NIST Provides Important Guidance For IOT Industry

Mintz - Privacy & Cybersecurity Viewpoints on 6/22/2020

More prevalent than ever before, Internet of Things (“IOT”) devices, a term that includes connected “smart” devices, such as internet connected TVs, wearables, smart speakers, such as the Amazon Echo and Google Home, are fast...more

Tracking State and Local Orders and Reopening Guidance Affecting Manufacturing and Warehousing Operations

Parker Poe Adams & Bernstein LLP on 4/21/2020

After New York and California issued stay at home orders on March 18 and 19, most other U.S. states have followed suit. As the rate of new COVID-19 infections is beginning to flatten in parts of the country, President Donald...more

Manufacturers of Instruments Routinely Used in In Vitro Diagnostics Should Carefully Consider FDA's Recent Cybersecurity Guidance

Wilson Sonsini Goodrich & Rosati on 12/6/2018

High throughput sequencers, including next generation, or NGS, sequencers; polymerase chain reaction, or PCR, machines; flow cytometers; and other instruments are routinely used in conducting in vitro diagnostic assays. Many...more

10 Results

View per page

Page: of 1

Cybersecurity › New Guidance › Manufacturers

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