Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun))

ICR 202005-0910-012

OMB: 0910-0471

Federal Form Document

Forms and Documents
Form and Instruction
Supporting Statement B
Supporting Statement A
IC Document Collections
ICR Details
0910-0471 202005-0910-012
Active 201704-0910-009
Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun))
Extension without change of a currently approved collection   No
Approved without change 07/31/2020
Retrieve Notice of Action (NOA) 06/29/2020
  Inventory as of this Action Requested Previously Approved
07/31/2023 36 Months From Approved 07/31/2020
5,400 0 3,750
2,700 0 2,813
0 0 0

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.

US Code: 21 USC 360c Name of Law: FFDCA; Medical Devices for Human Use

Not associated with rulemaking

  84 FR 49526 09/20/2019
85 FR 28954 05/14/2020

IC Title Form No. Form Name
Medical Product Reporting Network (MedSun) FDA 3670 MedSun

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 5,400 3,750 0 0 1,650 0
Annual Time Burden (Hours) 2,700 2,813 0 0 -113 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Our estimated burden for the information collection reflects an overall decrease of 113 hours despite a corresponding increase of 1,650 responses. We attribute this to more participants but increased IT effeiciencies.

Yes Part B of Supporting Statement
Jonna Capezzuto 301 796-3794 [email protected]


On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

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