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Draft Guidance Tackles Common Errors In Adverse Event Reporting

A revised guidance on medical device reporting fleshes out FDA’s thinking on manufacturers’ responsibilities in various situations.

FDA issued a revised guidance on its medical device reporting requirements for manufacturers, including a new “frequently asked questions” section and a list of common errors made by device companies in their adverse event reports to FDA.

The draft guidance, which will replace FDA’s 1988 and 1997 MDR guidances once finalized, explains FDA’s regulations for manufacturer adverse event reporting and recordkeeping and clarifies the agency’s interpretations of...

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