News & Analysis as of

Machine Learning Regulatory Oversight New Guidance

Morgan Lewis - As Prescribed

Key Takeaways from the AI Trends in Medical Devices Panel at the 2025 FDLI Annual Conference

Ariel Seeley served on the panel titled AI Trends in Medical Devices: Global Developments, FDA Policies, and Software as a Medical Device at the 2025 Food and Drug Law Institute (FDLI) Annual Conference. The panel provided an...more

Morgan Lewis - As Prescribed

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

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

Sheppard Mullin Richter & Hampton LLP

Copyright Office Report on Training AI and Fair Use

The Copyright Office released a “Pre-publication” version of Part 3 of its Report on Copyright and AI. Coincidentally (?) Shira Perlmuter, the Register of Copyrights, was fired amid a shakeup at the Copyright Office. The...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

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

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