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# Comments Sought on MedSun Reporting Requirements
- URL: https://www.fdaweb.com/comments-sought-on-medsun-reporting-requirements/
- Published: 2017-05-26T12:00:00.000Z
- Updated: 2026-09-14T22:25:57.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5138796

*Federal Register* notice: FDA is seeking comments on an information collection extension on “Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun)).” FDA regulation authorizes it to require manufacturers to report medical device-related deaths, serious injuries, and malfunctions. It also requires 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.gpo.gov/fdsys/pkg/FR-2017-05-26/pdf/2017-10844.pdf?ref=fdaweb.com).