Medical Devices

U.S. FDA uses judgment in applying standards for medical devices

Published in Medical Letter on the CDC and FDA, January 8th, 2006

The United States Food and Drug Administration (U.S. FDA) uses judgment in applying standards for medical devices.

According to a report from the United States, "In keeping with its mandate to provide the least burdensome means of product regulation, the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health uses many different standards to facilitate the review of premarket submissions of medical devices. The benefits of using standards in this manner include providing a set of common requirements and test protocols to the device manufacturer, thus reducing the manufacturer's need to 'reinvent the wheel' for each new bench test to ensure...

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Source: Medical Letter on the CDC and FDA (2006-01-08)

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