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Medical Devices › Artificial Intelligence › Rulemaking Process

Morgan Lewis

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

Morgan Lewis on

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

Polsinelli

FDA 2023-24: A Look Back & A Peek Forward

Polsinelli on

Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential election year, some FDA decisions (increased...more

Gardner Law

The Evolving FDA Regulatory Landscape of Artificial Intelligence

Gardner Law on

As artificial intelligence technology evolves on a seemingly minute-by-minute basis, the U.S. FDA’s regulatory approach continues to evolve in an effort to keep pace. “The promise of artificial intelligence in medicine is...more

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