Ariel Seeley

Ariel Seeley

Morgan Lewis

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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

Key Messaging from ‘Aging Technology, Emerging Threats: Examining Cybersecurity Vulnerabilities in Legacy Medical Devices’

On April 1, 2025, the subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce held a hearing on cybersecurity vulnerabilities in legacy medical devices. The hearing was largely a...more

4/10/2025  /  Cybersecurity , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Hospitals , Manufacturers , Medical Devices , New Guidance , Regulatory Requirements , Risk Assessment , Risk Management
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