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

Authors

Alexander O Everhart, Washington University School of Medicine in St. Louis
Pinar Karaca-Mandic, University of Minnesota
Rita F Redberg, University of California San Francisco
Joseph S Ross, Yale University
Sanket S Dhruva, University of California San Francisco

Journal

BMJ

Publication Date

3-12-2025

Volume

388

First Page

e081518

Document Type

Open Access Publication

DOI

10.1136/bmj-2024-081518

Rights and Permissions

Everhart AO, Karaca-Mandic P, Redberg RF, Ross JS, Dhruva SS. Late adverse event reporting from medical device manufacturers to the US Food and Drug Administration: cross sectional study. BMJ. 2025 Mar 12;388:e081518. doi: 10.1136/bmj-2024-081518. http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

Recommended Citation

Everhart, Alexander O; Karaca-Mandic, Pinar; Redberg, Rita F; Ross, Joseph S; and Dhruva, Sanket S, "Late adverse event reporting from medical device manufacturers to the US Food and Drug Administration: Cross sectional study." BMJ. 388, e081518 (2025).
https://digitalcommons.wustl.edu/oa_4/5303

Department

ICTS (Institute of Clinical and Translational Sciences)

Additional Links

Supplemental material is available for this article at publisher site.