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Software Data Management Regulatory Requirements

Hogan Lovells

New guidance on AI-enabled device software functions clarifies information FDA expects in marketing applications

Hogan Lovells on

On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which...more

King & Spalding

FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions

King & Spalding on

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more

Orrick, Herrington & Sutcliffe LLP

FDA Issues Draft Guidance on AI-Enabled Medical Devices

The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices. The Importance of Engaging Early Sponsors of AI-enabled devices should engage with the...more

Reveal

AI in eDiscovery: Highlights from the ACEDS Benelux Chapter Event

Reveal on

On May 30, 2024, the Benelux Chapter of the Association of Certified eDiscovery Specialists (ACEDS) hosted a highly anticipated event in collaboration with Reveal and Houthoff in Amsterdam. This exclusive gathering brought...more

Mitratech Holdings, Inc

20/20 for 2020: Bold Legal Ops Predictions for the New Year

It’s that season again; not just for celebrating a new year, but for making predictions about it…and beyond. Especially when it comes to what may lie ahead in Legal Ops, data privacy, and information governance. ...more

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