December 22, 2017 / 3:59 PM / in a year

FDA proposes program to streamline reporting of device malfunctions

Dec 22 (Reuters) - The U.S. Food and Drug Administration on Friday proposed a new program to streamline the reporting of medical device malfunctions by manufacturers.

“While manufacturers must report certain device malfunctions to the FDA, these individual reports often describe the same problem, creating a process where the FDA conducts duplicate reviews of common malfunctions,” the regulator said.

The FDA will still require medical device makers to file individual reports on deaths and serious injuries associated with devices. (Reporting by Manas Mishra in Bengaluru)

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