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Machine Learning Medical Devices Data Management

McDermott Will & Emery

FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances

McDermott Will & Emery on

Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more

Troutman Pepper Locke

2025 SCOPE Conference Emphasizes AI and Better Technologies to Improve Patient Outcomes

Troutman Pepper Locke on

The 2025 SCOPE Conference (Summit for Clinical Ops Executives), held last week in Orlando, FL, brought together more than 4,500 industry leaders, innovators, and experts in the clinical operations field. ...more

Knobbe Martens

FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development

Knobbe Martens on

The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products

FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s safety, effectiveness, or...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On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which...more

Faegre Drinker Biddle & Reath LLP

FDA Makes Draft Guidance Available on Lifecycle Management and Marketing Submission Recommendations for AI-Enabled Device Software...

On January 7, 2025, FDA published “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff”...more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FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions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

Foley & Lardner LLP

AI-Enabled Device Software Functions: FDA’s Final Guidance for Predetermined Change Control Plans

Foley & Lardner LLP on

On December 4, 2024, the U.S. Food & Drug Administration (FDA) released its Marketing Submissions for a Predetermined Change Control Plan (PCCP) for Artificial Intelligence-Enabled Device Software Functions (AI-DFS) final...more

McDermott Will & Emery

The Impact of the New EU AI Act on the Medtech and Life Sciences Sector

McDermott Will & Emery on

As technology continues to advance almost every aspect of healthcare, so the use of AI has become an increasing focus for developers and the regulators who are racing to keep pace with rapid advancements in technology. ...more

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