Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Program for Medical Devices: (Medical Product Safety Network (MedSun))

Issuing agencies

Abstract

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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<title>Federal Register, Volume 91 Issue 194 (Thursday, October 8, 2026)</title>
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[Federal Register Volume 91, Number 194 (Thursday, October 8, 2026)]
[Notices]
[Pages 64380-64381]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20661]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-N-7129]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Adverse Event Program 
for Medical Devices: (Medical Product Safety Network (MedSun))

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by November 9, 2026.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0471. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Barrett, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
<a href="/cdn-cgi/l/email-protection#36666477654257505076505257185e5e4518515940"><span class="__cf_email__" data-cfemail="207072617354414646604644410e4848530e474f56">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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

OMB Control Number 0910-0471--Extension

    Section 519 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 360i) authorizes FDA to require: (1) manufacturers to report 
medical device-related deaths, serious injuries, and malfunctions and 
(2) user facilities to report device-related deaths directly to 
manufacturers and FDA and serious injuries to the manufacturer. Section 
213 of the Food and Drug Administration Modernization Act of 1997 (Pub. 
L. 105-115) amended section 519(b) of the FD&C Act relating to 
mandatory reporting by user facilities of deaths, serious injuries, and 
serious illnesses associated with the use of medical devices. This 
amendment legislated the replacement of universal user facility 
reporting by a system that is limited to a ``. . . subset of user 
facilities that constitutes a representative profile of user reports'' 
for device-related deaths and serious injuries. This amendment is 
reflected in section 519(b)(5)(A) of the FD&C Act (21 U.S.C. 
360i(b)(5)(A)). This legislation provides FDA with the opportunity to 
design and implement a national surveillance network, composed of well-
trained clinical facilities, to provide high-quality data on medical 
devices in clinical use. This system is called MedSun. FDA is seeking 
OMB clearance to continue to use electronic data collection to obtain 
information related to medical devices and tissue products from the 
user facilities participating in MedSun, to obtain a demographic 
profile of the facilities, and for additional questions, which will 
permit FDA to better understand the cause of reported adverse events. 
Participation in

[[Page 64381]]

the program is voluntary and includes approximately 300 facilities. In 
addition to collecting data on the electronic adverse event report 
form, MedSun collects additional information from participating sites 
about reported problems emerging from the MedSun hospitals. This data 
collection is also voluntary and is collected on the same website as 
the report information. The burden estimate is based on the number of 
facilities participating in MedSun (300). FDA estimates an average of 
18 reports per site annually. This estimate is based on MedSun working 
to promote reporting in general from the sites, as well as promoting 
reporting from specific parts of the hospitals, such as the pediatric 
intensive care units, the electrophysiology laboratories, and the 
hospital laboratories.
    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 one comment, 
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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                  Number of
                  Activity                       Number of      responses per     Total annual         Average burden per response         Total hours
                                                respondents       respondent       responses
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Adverse Event Reporting.....................             300               18            5,400   .5 (30 minutes).......................           2,700
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-20661 Filed 10-7-26; 8:45 am]
BILLING CODE 4164-01-P


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