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Hogan Lovells

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

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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

Morgan Lewis

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

Morgan Lewis on

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

Troutman Pepper Locke

New FDA Guidance on AI and Medical Products

Troutman Pepper Locke on

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

BakerHostetler

Cybersecurity in Medical Devices

BakerHostetler on

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

Latham & Watkins LLP

NHTSA Updates Cybersecurity Best Practices for the Safety of New Vehicles

Latham & Watkins LLP on

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

Hogan Lovells

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

Hogan Lovells on

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

Mintz - Privacy & Cybersecurity Viewpoints

NIST Provides Important Guidance For IOT Industry

Mintz - Privacy & Cybersecurity Viewpoints on

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

Parker Poe Adams & Bernstein LLP

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

Parker Poe Adams & Bernstein LLP on

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

Wilson Sonsini Goodrich & Rosati

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

Wilson Sonsini Goodrich & Rosati on

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

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