Late adverse event reporting from medical device manufacturers to the US Food and Drug Administration: cross sectional study.

Abstract

To describe the extent of late adverse event reporting by manufacturers to the US Food and Drug Administration's (FDA) Manufacturer And User Facility Device Experience (MAUDE) database as well as the distribution of late reporting among manufacturers and associations with device characteristics. Cross sectional study. The FDA MAUDE database, a central postmarket safety surveillance tool for US medical devices, from 1 September 2019 to 31 December 2022. Medical device manufacturers that submitted