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Risk Management Draft Guidance Risk Assessment

ArentFox Schiff

FDA Issues New Recommendations on Use of AI for Medical Devices, Drugs, and Biologics

ArentFox Schiff on

In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics,...more

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On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which...more

Pillsbury Winthrop Shaw Pittman LLP

Department of Commerce Releases Five Products to Help Guide AI Development

The Department of Commerce released three final guidance documents incorporating public comments from earlier this spring which provide recommendations for managing AI risk, securing AI software development processes, and...more

Gardner Law

The Buzz on Med Device Cybersecurity

Gardner Law on

Medical device cybersecurity continues to create buzz, as the FBI issues a Private Industry Notification to health care providers outlining cybersecurity risks for medical devices. This follows FDA’s released Draft Guidance...more

Pillsbury Winthrop Shaw Pittman LLP

A Lifelong Commitment: FDA Releases Postmarket Guidance on Cybersecurity Risk Management for Medical Device Manufacturers

On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance titled “Postmarket Management of Cybersecurity in Medical Devices,” setting forth proposed recommendations for the medical device industry as...more

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