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

ICR 201404-0910-011

OMB: 0910-0471

Federal Form Document

Forms and Documents
Form and Instruction
Supporting Statement B
Supporting Statement A
IC Document Collections
37668 Modified
ICR Details
0910-0471 201404-0910-011
Historical Active 201110-0910-009
Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun))
Extension without change of a currently approved collection   No
Approved without change 05/23/2014
Retrieve Notice of Action (NOA) 04/22/2014
  Inventory as of this Action Requested Previously Approved
05/31/2017 36 Months From Approved 05/31/2014
3,750 0 6,000
2,813 0 4,500
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 360 Name of Law: null

Not associated with rulemaking

  78 FR 71620 11/29/2013
79 FR 20887 04/14/2014

IC Title Form No. Form Name
Adverse Event Reporting FDA 3670, FDA 3670, FDA 3670, FDA 3670, FDA 3670, FDA 3670 MedSun Database Additional Questions ,   MedSun Database Contact Screen ,   MedSun Database Device Screen ,   MedSun Database Event Screen ,   MedSun Database Patient Screen ,   MedSun Database Test Screen

  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 3,750 6,000 0 0 -2,250 0
Annual Time Burden (Hours) 2,813 4,500 0 0 -1,687 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Miscellaneous Actions
We have updated the title of this collection to reflect that the program is no longer in its pilot phase. We have estimated a reduced number of respondents (formerly 400, now 250) because we have determined that number to provide a roughly representative sample of small, medium, and large hospitals across the country (see further explanation in part B.1 of this supporting statement) and because we are currently receiving more reports than we can manage given our current resources. This adjustment has resulted in a decrease of 1,687 burden hours.

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.

© 2024 | Privacy Policy