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# Info Collection Extension on MedSun Reporting
- URL: https://www.fdaweb.com/info-collection-extension-on-medsun-reporting/
- Published: 2020-05-13T12:00:00.000Z
- Updated: 2026-09-14T16:14:49.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5146777

*Federal Register* notice: FDA has submitted to OMB an information collection extension for “Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun))” (OMB Control Number 0910-0471). The collection supports FDA regulations that 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://s3.amazonaws.com/public-inspection.federalregister.gov/2020-10353.pdf?ref=fdaweb.com).