Devices

FDA Reports on Device Safety, Innovation

CDRH has released two reports on medical device safety and innovation. The reports have summaries of the Center’s accomplishments and planned initiatives for the future.

They say that over a decade ago CDRH established a new vision for the Center based on the pillars of safety and innovation.

“We took an approach that both advances and interweaves our innovation and safety priorities,” CDRH says. “As device technology continues to evolve and the types of medical devices expand exponentially, we are mindful that the ways in which we assure reasonable device safety must also keep pace. Therefore, in parallel to our efforts to advance device innovation, we took and continue to take actions to improve the safety and our ability to identify and address safety concerns of devices.”

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome