Evaluation of reporting trends in the MAUDE Database: 1991 to 2022.

ABSTRACT: Adverse event reporting for medical devices is critical for risk mitigation. The Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database serves as a key tool for post-market surveillance, receiving reports from various sources. Ensuring information integrity, especially across diverse reporting sources, is paramount. Periodic regulatory updates aim to enhance reporting.

Objective

Analyze reporting patterns, assess the potential contribution of 2015 and 2018 regulatory updates on reporting rates for varies reporters. Additionally, evaluating reporting schedule compliance by comparing average reporting times to regulatory requirements for these reporters.

Methods

Data from 1991-2022 was retrieved from the MAUDE database. Annual rep

SUBMITTER: Mishali M 

PROVIDER: S-EPMC11755539 | biostudies-literature | 2025 Jan-Dec

REPOSITORIES: biostudies-literature