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Software Labeling

McDermott+

FDA Issues Final Guidance on Predetermined Change Control Plans for AI-Enabled Devices

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On December 3, 2024, the US Food and Drug Administration (FDA) published final guidance titled, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software...more

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

Lerman Senter PLLC

FCC Launches U.S. Cyber Trust Mark Program

Lerman Senter PLLC on

The Federal Communications Commission has created a voluntary cybersecurity labeling program, also known as the “U.S. Cyber Trust Mark program,” for wireless consumer Internet of Things (IoT) products. The FCC is seeking...more

Foley Hoag LLP

FDA and Prescription Drug Use Related Software – FDA’s Draft PDURS Guidance Answers Years-Old Questions and Introduces New Ones

Foley Hoag LLP on

After remaining silent on the topic for decades, the Food and Drug Administration (FDA) provided an expansive definition of “promotional labeling” in its recently issued draft guidance document on Regulatory Considerations...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

Labeling Devices for Cybersecurity Protection

Takeaway: Security labels on internet-connected devices are on the horizon for companies that manufacture and want to sell such devices worldwide. On October 19, 2022, 50 representatives from different industries including...more

Wiley Rein LLP

Wireless Roundup (March 2022)

Wiley Rein LLP on

Key Wireless Deadlines- NIST Requests Comment on Staging Cybersecurity Risks for Enterprise Risk Management and Governance Oversight: The National Institute of Standards and Technology (NIST) seeks comment on Draft NISTIR...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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