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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

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 10, December 2024

Spilman Thomas & Battle, PLLC on

Happy Holidays and welcome to our year-end issue of Decoded. We hope you enjoyed reading our technology law insights e-newsletter this year. We are already planning for 2025. ...more

Jones Day

Radical Changes to Europe's Product Liability Rules Adopted

Jones Day on

Dramatic changes to EU product liability rules are expected to drive an increase in litigation....more

Goodwin

EU Adopts Cyber Resilience Act for Connected Devices

Goodwin on

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

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