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FDA Collects More Demographics Data In MAUDE

 
• By Elizabeth Orr

The adverse event database will now collect patient age, weight, ethnicity and race, which aligns with recent FDA efforts to better track information on how medical products may affect people from different demographic groups. 

Someone completing an online form.
• Source: Shutterstock

People reporting device-related adverse events to the US Food and Drug Administration can now include more information about the affected patients, the agency announced today.

The Manufacturer and User Facility Device Experience (MAUDE), as well as the openFDA data endpoint, have been updated to include fields for patient age, weight, ethnicity and race

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