Tag: Food and Drug Administration (FDA)

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How Does The FDA Administer Medical Device Recalls?

May 6, 2019

A recall is the process of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA). Medical device recalls are initiated one of two ways: In most cases, a manufacturer, distributor, or otherwise responsible party voluntarily recalls a medical device without any direction from the FDA. When […]

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Blog

FDA Changes Approval Process For Medical Devices

February 18, 2019

In hoping to ensure that new medical devices reflect modern safety and effectiveness features, the FDA is revising its process for approving medical devices. In modernizing the approval process, the FDA wants to compel companies to base products on devices that are not older than 10 years. For many years, the Food and Drug Administration’s […]

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