Federal Register #FDA-2026-N-7129

FDA Requests Public Comment on MedSun Adverse Event Information Collection

This notice from the Food and Drug Administration (FDA), under the Department of Health and Human Services, seeks public comment on its proposed information collection for the Adverse Event Program for Medical Devices (MedSun). - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Program Overview: - MedSun (Medical Product Safety Network) Adverse Event Program - Involves approximately 300 user facilities voluntarily reporting adverse events related to medical devices - Purpose: - Collects data to improve medical device safety and understand causes of adverse events - Seeks feedback on the information collection process and its burden on participants - OEMs and Vendors: - No specific OEMs or vendors are mentioned - Products/Services Requested: - No products or services are being procured - Unique Requirements: - Focus is on voluntary reporting and evaluation of the information collection process, not procurement

Description

The Food and Drug Administration (FDA) is seeking public comments on the proposed collection of information related to the Adverse Event Program for Medical Devices, part of the Medical Product Safety Network (MedSun). This program involves voluntary participation from approximately 300 user facilities to report adverse events related to medical devices. The FDA uses this data to better understand the causes of reported adverse events and improve medical device safety. Comments on the collection of information must be submitted by September 15, 2026.

View original listing