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FDA Proposes Easing of Medical Device Malfunctioning Reporting

biospaceDecember 26, 2017

Tag: FDA , 4/5000 Shèbèi gùzhàng Equipment failure

The U.S. Food and Drug Administration on Friday said it plans to let medical device makers report less serious malfunctions of some devices on a quarterly basis to cut down on repeated reviews of common problems.

The FDA said in a statement that it is proposing to allow the manufacturers to report certain malfunctions in summary reports, rather than having to file individual reports for each malfunction. They would still be required to file individual reports for deaths and serious injuries, the agency said.

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