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# Info Collection on Device Adverse Event Program
- URL: https://www.fdaweb.com/info-collection-on-device-adverse-event-program/
- Published: 2023-01-19T12:00:00.000Z
- Updated: 2026-09-14T18:12:28.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153568

*Federal Register* notice: FDA is seeking comments on an information collection extension entitled “Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun)).” Agency regulations authorize FDA to require: (**1**) manufacturers to report medical device-related deaths, serious injuries, and malfunctions and (**2**) user facilities to report device-related deaths directly to manufacturers and FDA and serious injuries to the manufacturer. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-01-19/pdf/2023-00926.pdf?ref=fdaweb.com).