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Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more

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2023, the Food and Drug Administration (FDA) published in the Federal Register an announcement of availability for the draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan...more

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

Stinson LLP

FDA Attempts to Clarify Enforcement Position Regarding Evolving Health Technology

Stinson LLP on

Recently, the U.S. Food and Drug Administration (FDA) has issued a flurry of guidance and draft guidance in an effort to better define the types of products that the FDA will choose to actively regulate. In one of these...more

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