Elizabeth Lawless

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Latest Posts › Medical Devices

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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

FDA’s Rare Disease Innovation Hub Releases Strategic Agenda: Implications for Stakeholders in 2025

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more

2/6/2025 / Food and Drug Administration (FDA) , Innovation , Life Sciences , Medical Devices , Pharmaceutical Industry , Regulatory Agenda , Regulatory Requirements

How New Executive Orders May Affect FDA’s Medical Device Operations

Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration (FDA) and its regulatory oversight for medical device and digital health...more

2/3/2025 / Artificial Intelligence , Digital Health , Executive Orders , Food and Drug Administration (FDA) , Medical Devices , Policy Updates , Regulatory Oversight , Regulatory Requirements , Trump Administration , World Health Organization

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