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A Primer to the Structure, Content and Linkage of the FDA’s Manufacturer and User Facility Device Experience (MAUDE) Files

2017-06-14

Abstract excerpt

Introduction and Background: The US Food and Drug Administration (FDA)'s Manufacturer and User Facility Device Experience (MAUDE) database is a publicly available resource providing over 4 million records relating to medical device safety. Using downloadable MAUDE files avoids limitations of the online MAUDE search interface. However, naïve file usage can result in errors, while independent discovery of the nuance...

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Literature Corpus work
bc715b81-f056-5ab0-a863-3d890eca6f4a
DOI
10.13063/egems.1253
Open publication

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