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United States Food and Drug Administration
ADVERSE EVENT PROGRAM FOR MEDICAL DEVICES: (MEDICAL PRODUCT SAFETY NETWORK (MEDSUN))
OMB Control No. 0910-0471 – EXTENSION
SUPPORTING STATEMENT
Part A: Justification:
    1. Circumstances Making the Collection of Information Necessary
This information collection supports the Food and Drug Administration (FDA, the agency, us or we) Medical Product Safety Network (MedSun) program, a national reporting system mandated under the Food and Drug Administration Modernization Act (FDAMA) of 1997 to collect data regarding medical device reports associated with medical device related deaths, serious injuries, and malfunctions.  Provisions in section 213 of FDAMA amended section 519(b) of the FD&C Act (21 U.S.C. 360i(b)), to require universal user facility reporting with a system limited to a “…subset of other user facilities that constitutes a representative profile of user reports for device deaths and serious illnesses or serious injuries.” The MedSun program includes three primary data collection components: 
    (1) demographic profile information about the participating facilities; 
    (2) portions of information participating facilities are already mandated to report regarding adverse events; and 
    (3) additional voluntary questions. 
 
Accordingly, we are requesting extension of OMB approval for the information collection provisions included in our MedSun program and discussed in this supporting statement.
 
    2. Purpose and Use of the Information Collection
We rely 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 us with the ability to have a dialogue with the clinical community and work together to learn about, understand, and solve problems with the use of medical devices in the clinical setting.  
MedSun reports are triaged in the same manner as other reported device problems based on perceived risk to the patient.  Some reports signal an immediate hazard, but more commonly it is the experienced FDA clinical staff who detect product problems, particularly those related to product use, through careful investigation of reported incidents and by searching for additional sources of information.  The degree of perceived risk to the public is the most important consideration for any FDA public health action (product recall, Safety Alert, Public Health Notification, Action Team, Safety Tip, workshop, publication, etc.).  
Clinical staff, epidemiologists, biomedical engineers and other FDA scientists access the MedSun reports to answer questions of risk assessment and to determine if there are signals which may indicate that actions may be needed to protect the public health.  The MedSun reports have often been the initial signal to FDA that a problem was occurring with the use of a device in the clinical community.  This has led to letters to manufacturers to learn more about the causes and solutions to the problems, led to Center Wide Workgroups to address the problems, Rapid Response Surveys, articles, and Public Health Notifications. 

The MedSun reports are redacted and are placed nightly on the publicly available FDA MedSun website, and monthly on the FDA Manufacturer and User Facility Device Experience (MAUDE) website, so the public may view reports about problems with medical devices.  The MedSun program has provided a dimension to FDA’s understanding of how, why, and when medical devices are used in the clinical community once the devices have been cleared for marketing, and the types of problems that occur once products are in widespread use.  Before MedSun, FDA had little contact with the users of the medical devices, and the reports that were received from the clinical community were lacking in important details. Even though there is mandatory reporting for hospitals and other user facilities, under-reporting was a huge problem prior to MedSun.  MedSun was specifically developed to overcome the under-reporting problem, at least from a subset of facilities in the country.  FDA has come to rely on this excellent relationship with the clinical community. If MedSun is not permitted to continue, this valuable tool for information gathering will no longer be available to FDA. 

    3. Use of Improved Information Technology and Burden Reduction
The MedSun data collection is an internet-based data collection system.  The MedSun reporters access the reporting form at a secure internet-based website (see https://medsun.fda.gov/FDA/).  They may type each report in separately or upload the data into the MedSun software from a file downloaded from their own internal systems – all through the same secure web site.  The MedSun system complies with subpart B, § 1.11 (for closed systems) of 21 CFR part 11, where appropriate.  Our respondents tell us they greatly appreciate the ease of using our online tool.  We receive 99% of the MedSun reports online.  The remaining 1% is taken over the phone or by fax when the either the MedSun site is having a software issue, or the MedSun site is down for maintenance. 

    4. Efforts to Identify Duplication and Use of Similar Information 
We are unaware of duplicative information.  Although we maintain other information collection associated with adverse events, this collection specifically aligns with statutory objectives for data assessment associated with medical device product use.  

    5. Impact on Small Businesses or Other Small Entities
There is no undue burden imposed on small entities who may be subject to the information collection.  At the same time, we provide resources to small businesses on our website, along with staff to assist small businesses in complying with regulatory requirements. 

    6. Consequences of Collecting the Information Less Frequently
The information collection schedule is consistent with statutory and regulatory requirements. 
    7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information. 

    8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency
In the Federal Register of July 17, 2026 (91 FR 44863), FDA published a 60-day notice soliciting public comment on the proposed extension of OMB Control Number 0910-0471. FDA received two comments which were determined to be PRA-related.
The first comment was submitted by an individual quality engineer with professional experience in medical device manufacturing, adverse event investigation, and CAPA program management. The commenter expressed support for the extension of the MedSun collection and offered suggestions in response to each of the four questions posed in the notice.
With respect to cost and hour burden, the commenter questioned the accuracy of the 30-minute-per-response estimate, noting that complex reports — particularly those involving serious injury, death, or multiple interacting devices — likely require significantly more time, especially in the specialty clinical environments FDA is actively recruiting (e.g., pediatric ICUs, electrophysiology labs). The commenter recommended that FDA validate the estimate against a stratified sample of actual reports broken out by complexity level, and that supplemental follow-up questions be counted as a separate burden line item, as they involve additional staff time not captured in the initial submission estimate.
The current estimate of 0.5 hours per response reflects the average burden across all report types based on historical data and network feedback, and FDA considers it a reasonable approximation for PRA purposes. FDA will consider stratified burden estimation in the next renewal cycle.
The commenter also suggested several data quality and efficiency improvements — including adoption of IMDRF adverse event codes, UDI prompting with auto-population, a tiered short/long form structure, EHR integration via FHIR-based exchange, and the provision of aggregate feedback to participating sites. While these suggestions are outside the scope of the current PRA clearance, FDA will consider them in the context of ongoing MedSun program development and future collection instrument updates.
The second comment was submitted by an individual responding to the first commenter. Although not a traditional PRA comment, FDA considered it PRA related in that the commenter expressed agreement with FDA's approach to the MedSun program and affirmed the value of maintaining a small, trained sentinel network producing high-quality adverse event data. The commenter's support for FDA's position further corroborates the continued utility and public confidence in the MedSun collection. FDA acknowledges this comment and notes that it is consistent with the agency's rationale for extending this information collection.
    9. Explanation of Any Payment or Gift to Respondents
Respondents receive no payment for their participation in the MedSun program.  Small reminders, to aid in prompting reporting, are provided during the sites’ participation (e.g., posters for the sites to hang in areas where clinical staff will see them and badge cards for the healthcare professionals to wear that list the elements of a good report).  These reminders are very important because the MedSun representatives are very busy people in their respective facilities and FDA is asking them to make time to contribute to the public health by reporting not only the mandatory device events (deaths and serious injuries), but also voluntary reports of ‘close-calls’ and ‘potential for harm’ events.  Approximately 90% of the reports we receive in MedSun fall into the ‘voluntary’ category.  These reports are extremely useful to FDA.  They help the agency detect possible early problems with devices.  It is important to the program to provide reminders to those reporting so they remember to send these voluntary reports.    

    10. Assurance of Confidentiality Provided to Respondents
 The Privacy Act of 1974 (5 U.S.C. 552a)

In preparing this Supporting Statement, we consulted our Privacy Office to ensure appropriate identification and handling of information collected.

This ICR collects personally identifiable information (PII).  PII is collected in the context of collecting medical device report information from facilities participating in MedSun event reporting. Most data elements collected describe adverse events or potential for harm events (e.g. near misses) associated with medical devices and experienced at hospitals. The PII submitted via Form FDA 3670 (MedSun Medical Product Safety Network Report) is patient identifier, patient date of birth, patient demographics, patient medical history, device manufacturer address, facility reporter name, reporter work address, reporter work phone number, reporter work fax number, and reporter work email address. FDA determined that although PII is collected, the collection is not subject to the Privacy Act of 1974 and the particular notice and other requirements of the Act do not apply. Specifically, the contractor or FDA does not use name or any other personal identifier to retrieve records from the information collected. Through appropriate form and webpage design, FDA limited submission fields and minimized the PII collected to protect the privacy of the individuals.

The Freedom of Information Act (FOIA)

Under FOIA (5 U.S.C. 552), the public has broad access to government documents. However, FOIA provides certain exemptions from mandatory public disclosure of government records (5 U.S.C. 552(b) (1-9)).  FDA will make the fullest possible disclosure of records to the public (see 21 CFR 20), consistent with the rights of individuals to privacy, the property rights of persons in trade and confidential commercial or financial information.

    11. Justification for Sensitive Questions
This information collection does not include questions pertaining to sexual behavior, attitude, religious beliefs, or any other matters that are commonly considered private or sensitive in nature.  The system collects the OMB cleared information of the age and weight of the patient (no names or social security numbers are collected).  It collects the name, phone number, and work address of the reporter for the reporting site.  None of this information is releasable to the public under the FD&C Act (section 519(b)(1)(D)(2)).
 
    12. Estimates of Annualized Burden Hours and Cost
12a.  Annualized Hour Burden Estimate
Table 1.--Estimated Annual Reporting Burden


Activity
No. of Respondents
No. of
Responses per Respondent
Total
Annual
Responses
Avg.
Burden per
Response
Total Hours
Adverse event reporting
300
18
5400
0.5
2,700

The burden estimate for the electronic reporting of adverse events is based on the number of facilities participating in MedSun (300).  We estimate an average of 18 reports per site annually.  We hope to reach this goal because FDA is working to promote reporting in general from the sites, as well as continuing to promote reporting from more specific parts of the hospital. 
Therefore, this yields a total estimate of 5,400 annual responses (300 facilities x 18 data entries = 5,400 reports).  The participating MedSun reporters tell FDA that it typically takes 30 minutes to fill out the online form.  Therefore, the overall annual burden hours will be 2,700 hours (5,400 report entries x 0.5 hours = 2,700 hours).
12b. Annualized Cost Burden Estimate 
The primary MedSun representative in each hospital is a Risk Manager.  It is anticipated that these representatives will complete the majority of the MedSun entries.  The median range salary of this professional group is $56.71 per hour.  The estimated annualized cost for MedSun respondents is 2,700 hours x $56.71 = $153,117.   
*Link for salary https://www.bls.gov/ooh/management/medical-and-health-services-managers.htm from the Bureau of Labor and Statistics Occupational and Employment and Wages data, May 2024 (occupation code 11-9111 Medical and Health Services Managers, General Medical and Surgical Hospitals was selected because there is no specific category for “Risk Managers of Hospitals”).
Type of Respondent
Total Burden Hours
Hourly Wage Rate
Total Respondent Costs
Risk Managers
2,700
$ 56.71
$153,117

    13. Estimates of Other Total Annual Costs to Respondents/Recordkeepers or Capital Costs 
There are no capital, start-up, operating or maintenance costs associated with this information collection.

    14. Annualized Cost to the Federal Government
The total cost of the MedSun project is related to the cost of 10 FDA full-time equivalent positions (FTEs) and the cost to maintain the system software. 
 
    15. Explanation for Program Changes or Adjustments*
There is no change in burden. This information collection is being submitted as an extension to the currently approved collection, with no programmatic changes. The estimated number of respondents, frequency of response, and hours per response remain unchanged from the previously approved collection. The total burden of 2700 hours is consistent with the prior OMB approval.
    16. Plans for Tabulation and Publication and Project Time Schedule
This is a data collection system where reporters submit problems with medical devices when used in the clinical environment.  All FDA collected adverse events about medical devices are posted on FDA websites.  These reports are fully redacted according to Freedom of Information (FOI) and statutory requirements. 
 
FDA analysts also publish case study articles which refer to redacted reports received from the MedSun reporters. 

    17. Reason(s) Display of OMB Expiration Date is Inappropriate
FDA will display the OMB expiration date as required by 5 CFR 1320.5. 

    18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.