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Regulatory Oversight › Machine Learning › Draft Guidance

Morgan Lewis - As Prescribed

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

Morgan Lewis - As Prescribed on

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

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

Akin Gump Strauss Hauer & Feld LLP

FDA Releases Action Plan for Artificial Intelligence/Machine Learning-Enabled Software as a Medical Device

Akin Gump Strauss Hauer & Feld LLP on

Key Points - FDA will publish draft guidance on its Predetermined Change Control Plan in 2021 and host a public workshop on transparency requirements around AI/ML-based devices. - FDA plans to pilot Real-World Performance...more

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