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Closing soon Health and Human Services Department, Food and Drug Administration Docket Docket No. FDA-2026-N-7129

FDA Seeks OMB Clearance for Medical Device Adverse Event Reporting Program (MedSun)

💬 Comments close in 7 days (Nov 9)

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Timeline

  1. Related document

    Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Devices: (Medical Product Safety Network (MedSun))

  2. Proposed / opened

    FDA Seeks OMB Clearance for Medical Device Adverse Event Reporting Program (MedSun)

  3. Related document

    Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Program for Medical Devices: (Medical Product Safety Network (MedSun))

Briefs in this proceeding

Notable FDA 💬 Comments close in 7 days (Nov 9)

FDA Seeks OMB Clearance for Medical Device Adverse Event Reporting Program (MedSun)

FDA's submission of the MedSun information collection for OMB review signals continued focus on post-market surveillance of medical devices through structured adverse event reporting. The Food and Drug Administration has submitted a proposed information collection request to the Office of...

Sources

Health and Human Services Department, Food and Drug Administration · Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Program for Medical Devices: (Medical Product Safety Network (MedSun)) · Oct 8