Ariel Seeley

Morgan Lewis

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Latest Posts › Regulatory Oversight

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Navigating Uncertainty in US FDA’s Center for Devices and Radiological Health Regulation of Medical Devices

The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and Radiological Health have seen a fluctuating workforce size, a slew of new executive...more

7/7/2025 / Artificial Intelligence , Department of Health and Human Services (HHS) , Digital Health , Executive Orders , Food and Drug Administration (FDA) , Medical Devices , Regulatory Oversight , Regulatory Reform , Regulatory Requirements , Rulemaking Process

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

6/11/2025 / Algorithms , Artificial Intelligence , Draft Guidance , Food and Drug Administration (FDA) , Machine Learning , Medical Devices , New Guidance , Regulatory Oversight , Regulatory Requirements

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

6/4/2025 / Artificial Intelligence , Draft Guidance , Food and Drug Administration (FDA) , Machine Learning , Medical Devices , New Guidance , Pharmaceutical Industry , Regulatory Oversight , Regulatory Requirements

Federal Court Blocks FDA’s Final Rule on LDTs: Key Considerations for Clinical Labs

The US District Court for the Eastern District of Texas issued a pivotal ruling in the consolidated lawsuit American Clinical Laboratory Association v. US Food and Drug Administration (FDA) challenging FDA’s final rule to end...more

4/22/2025 / Administrative Procedure Act , Centers for Medicare & Medicaid Services (CMS) , Clinical Laboratories , Food and Drug Administration (FDA) , Judicial Authority , Loper Bright Enterprises v Raimondo , Medical Devices , Regulatory Oversight , Regulatory Requirements

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