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Food and Drug Administration (FDA) Safety Standards Healthcare

DLA Piper

FDA in focus: 2024 in review and 2025 outlook

DLA Piper on

In 2024, the Food and Drug Administration (FDA) significantly invested in reorganizing its internal infrastructure and enhancing operations. These efforts aimed to address the complexities of a global supply chain, rapid...more

King & Spalding

GAO Issues Report on Artificial Intelligence in Health Care

King & Spalding on

On September 29, 2022, the United States Government Accountability Office (“GAO”) and the National Academy of Medicine (“NAM”) jointly published a detailed Report to Congressional Requesters titled Artificial Intelligence in...more

Sheppard Mullin Richter & Hampton LLP

FDA’s New Safety and Performance Based Pathway for Medical Devices Reflects a More Modern Approach to Finding Substantial...

On September 19, 2019, FDA issued a guidance document, “Safety and Performance Based Pathway,” describing an optional pathway for medical devices with well-understood safety and performance profiles. The guidance signals...more

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