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# Info Collection Extension on MedSun Reporting
- URL: https://www.fdaweb.com/info-collection-extension-on-medsun-reporting-2/
- Published: 2019-09-19T12:00:00.000Z
- Updated: 2026-09-15T01:51:08.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145043

*Federal Register* notice: FDA is seeking comments on an information collection extension for “Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun))” OMB Control Number 0910-0471\. The agency’s regulations authorize it 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://s3.amazonaws.com/public-inspection.federalregister.gov/2019-20355.pdf?ref=fdaweb.com).