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Ropes & Gray LLP

FDA Finalizes Guidance on Predetermined Change Control Plans for AI-Enabled Medical Device Software

Ropes & Gray LLP on

On December 4, 2024, the U.S. Food and Drug Administration (“FDA”) released its final guidance for industry on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence-enabled software...more

McDermott Will & Emery

NIST Publishes Draft Security Criteria for Consumer Software

McDermott Will & Emery on

Consumer software providers will soon have the option to label their software as compliant with National Institute of Standards and Technology (NIST) standards for software security. On November 1, 2021, NIST published its...more

Perkins Coie

President Biden’s Cybersecurity Executive Order Focuses on IT and Software Supply Chain Vulnerabilities

Perkins Coie on

On May 12, 2021, President Biden signed a sweeping Executive Order (EO) to protect federal government networks and software supply chains against increasing threats of attacks from malicious cyber actors, setting the stage...more

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