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

ABSTRACT:

Objective

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.

Design

Cross sectional study.

Setting

The FDA MAUDE database, a central postmarket safety surveillance tool for US medical devices, from 1 September 2019 to 31 December 2022.

Participants

Medical device manufacturers that submitted initial adverse event reports to the FDA between 1 September 2019 and 31 December 2022.

Main outcome measures

Time in days between date manufacturer was notified of event and date of FDA receipt of adverse event reports, prop

SUBMITTER: Everhart AO 

PROVIDER: S-EPMC11898541 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature