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Artificial Intelligence › New Guidance › Medical Devices

Morgan Lewis - As Prescribed

FDA’s AI-Assisted Review: The Next Stage of Regulated Product Evaluation

Morgan Lewis - As Prescribed on

On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool “modernizes agency functions and...more

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Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more

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

Jones Day

FDA's Final Guidance Provides Practical Approach for AI-Enabled Devices Implementing Post-Market Modifications

Jones Day on

As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more

WilmerHale

AI-Powered Medical Devices Bring Patent and Regulatory Pitfalls

WilmerHale on

Artificial intelligence and machine learning are transforming the medical device industry. Simultaneously, companies are working to gain Food and Drug Administration approval and obtain intellectual property protection for...more

Troutman Pepper Locke

New FDA Guidance on AI and Medical Products

Troutman Pepper Locke on

n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

Foley & Lardner LLP

FDA’s New Guidance Proposes Flexible Use of AI in Medical Devices

Foley & Lardner LLP on

On April 3, 2023, U.S. Food and Drug Administration (FDA) issued its much anticipated draft guidance, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more

Foley Hoag LLP

FDA Releases Guidance on Submissions for AI/ML-Enabled Devices

Foley Hoag LLP on

On April 3, 2023, the Food and Drug Administration (FDA) published in the Federal Register an announcement of availability for the draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan...more

McDermott Will & Emery

FDA Issues Good Machine Learning Practice Guiding Principles

McDermott Will & Emery on

On October 27, 2021, pursuant to the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan (Action Plan), the US Food and Drug Administration (FDA) released its Good Machine Learning...more

Foley Hoag LLP

Public Health Agencies Release “Guiding Principles” for Good Machine Learning Practice

Foley Hoag LLP on

The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) jointly issued a guidance document entitled, “Good Machine Learning Practice for...more

Sheppard Mullin Richter & Hampton LLP

New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning

Sheppard Mullin Richter & Hampton LLP on

On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The...more

Jones Day

Patenting Digital Health Innovations Incorporating AI in View of USPTO's Recent Subject Matter Eligibility Guidance

Jones Day on

Patent procurement activity is increasing to protect embedded artificial intelligence ("AI") technologies in a variety of digital healthcare solutions. The United States Patent and Trademark Office ("USPTO") has issued the...more

Knobbe Martens

FDA Expresses Priorities for Clinical Trial Efficiency, Artificial Intelligence

Knobbe Martens on

The FDA has announced new goals to help modernize its procedures and respond to new technologies. In a blog post by FDA Commissioner Scott Gottlieb, M.D., the agency expressed new priorities to help modernize clinical trials...more

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