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Glossary

Trend reporting

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A reporting type used by the manufacturer when a significant increase in events not normally considered to be incidents occurred and for which pre-defined trigger levels are used to determine the threshold for reporting. 

Other glossary definitions

P

Pre-Sub Meeting

FDA Pre-Sub meetings are available for manufacturers to obtain regulatory feedback on various medical device…

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I

Indication

A medical condition that a medicine is used for. This can include the treatment, prevention…

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