FDA seeks OK to keep collecting device mishap reports, yawn
Published Date: 10/8/2026
Notice
Summary
The FDA is asking for approval to keep collecting reports about problems with medical devices through its MedSun program. This affects medical device makers and certain hospitals that report serious injuries or deaths linked to devices. Comments on this plan are open until November 9, 2026, and there’s no new cost, just a continuation of current reporting rules.
Analyzed Economic Effects
2 provisions identified: 0 benefits, 2 costs, 0 mixed.
MedSun reporting continues for 300 hospitals
If you work at a hospital that participates in FDA's MedSun network, the voluntary data collection will continue. About 300 facilities participate, with an FDA estimate of 18 reports per site each year, 0.5 hours (30 minutes) per report, for a total of 5,400 reports and 2,700 hours of staff time annually.
Existing manufacturer and facility reporting obligations
Under section 519 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i), manufacturers must report medical device-related deaths, serious injuries, and malfunctions, and user facilities must report device-related deaths directly to manufacturers and FDA and serious injuries to the manufacturer. The MedSun system implements a voluntary national surveillance network limited to a subset of user facilities as a representative profile.
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