This ICR collects information for the Food and Drug Administration's Medical Product Safety Network (MedSun) program from a subset of medical device user facilities that constitutes a representative profile of user reports for device-related deaths and serious injuries related to medical devices. FDA relies on reports of product problems from consumers and health care professionals, as well as from device manufacturers, in order to understand if signals of product problems are emerging in the postmarket use environment. MedSun is a significant, and very successful, strategy used by FDA to understand problems with medical devices in use in hospitals and outpatient services associated with hospitals. The MedSun program is unique to FDA and provides FDA with the ability to have a dialogue with the clinical community, so they may work together to learn about, understand, and solve problems with the use of medical devices.
The latest form for Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun)) expires 2023-07-31 and can be found here.
Document Name |
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Form and Instruction |
Supporting Statement B |
Supporting Statement A |
Approved without change |
Extension without change of a currently approved collection | 2020-06-29 | |
Approved without change |
Extension without change of a currently approved collection | 2017-05-26 | |
Approved without change |
Extension without change of a currently approved collection | 2014-04-22 | |
Approved without change |
No material or nonsubstantive change to a currently approved collection | 2011-10-25 | |
Approved with change |
Revision of a currently approved collection | 2010-12-16 | |
Approved without change |
Extension without change of a currently approved collection | 2007-09-25 | |
Approved without change |
No material or nonsubstantive change to a currently approved collection | 2005-12-16 | |
Approved with change |
Extension without change of a currently approved collection | 2004-06-24 | |
Approved without change |
No material or nonsubstantive change to a currently approved collection | 2004-03-19 | |
Approved without change |
New collection (Request for a new OMB Control Number) | 2001-05-24 |