Review Of US Medical Device Regulation Published By Stanford Researchers

Researchers at the Stanford University Program in Biodesign have released a review of the background, mission and statutory requirements of medical device regulation in the United States. The report, published in the Journal of Medical Devices, highlights the differences between regulations guiding medical devices versus pharmaceuticals and underscores the complexity of the approval process and post-market surveillance administered by the Food and Drug Administration (FDA).

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Filed under: Medical Devices on January 12th, 2008