Notice2025-14230
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Reporting
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 29, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 143 (Tuesday, July 29, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 143 (Tuesday, July 29, 2025)]
[Notices]
[Pages 35698-35701]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14230]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0419]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Device
Reporting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 August 28, 2025.
ADDRESSES: To ensure that comments on the information collection are
received,
[[Page 35699]]
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 0910-0437. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, 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#e9b9bba8ba9d888f8fa98f8d88c781819ac78e869f"><span class="__cf_email__" data-cfemail="d8888a998bacb9bebe98bebcb9f6b0b0abf6bfb7ae">[email 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.
Medical Device Reporting--21 CFR Part 803
OMB Control Number 0910-0437--Revision
This information collection supports FDA regulations, programs,
forms, and guidance. Section 519 of the Federal Food Drug and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360i) (Records and Reports on Devices)
requires user facilities, manufacturers, and importers of medical
devices to report adverse events involving medical devices to FDA and
requires that medical device manufacturers and importers submit medical
device reports (MDRs) electronically. These provisions are codified at
part 803 (21 CFR part 803)--Medical Device Reporting. The regulations
also provide for recordkeeping requirements and certain exemptions and
alternative reporting. Additionally, the regulations permit user
facilities to submit paper-based annual reports, for which we have
provided form FDA 3419 entitled, ``Medical Device Reporting Annual User
Facility Report.''
Respondents are required to report adverse events involving medical
devices to the FDA. The information that is obtained from these reports
will be used to evaluate risks associated with medical devices and
enable FDA to take appropriate regulatory measures to protect the
public health. Complete, accurate, and timely adverse event information
is necessary for the identification of emerging device problems so the
agency can protect the public health under section 519 of the FD&C Act.
FDA makes the releasable information available to the public for
downloading on its website (<a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm">https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm</a>).
In an effort at reducing burden, we have developed the Voluntary
Malfunction Summary Reporting (VMSR) Program for certain devices, which
allows for respondent reporting of multiple malfunction events in a
single report on a quarterly basis. The VMSR Program was established
under section 519(a)(1)(B)(ii) of the FD&C Act. The associated FDA
notification and order granting alternative entitled, ``Medical Devices
and Device-led Combination Products; Voluntary Malfunction Summary
Reporting Program for Manufacturers'' (83 FR 40973; 8/17/2018; <a href="https://www.federalregister.gov/documents/2018/08/17/2018-17770/medical-devices-and-device-led-combination-products-voluntary-malfunction-summary-reporting-program">https://www.federalregister.gov/documents/2018/08/17/2018-17770/medical-devices-and-device-led-combination-products-voluntary-malfunction-summary-reporting-program</a>) grants an alternative under Sec. 803.19 to
permit manufacturer reporting of certain device malfunctions in summary
form on a quarterly basis. The associated FDA guidance entitled
``Voluntary Malfunction Summary Reporting (VMSR) Program for
Manufacturers'' (August 2024; <a href="https://www.fda.gov/media/163692/download">https://www.fda.gov/media/163692/download</a>) is intended to help manufacturers better understand and use
the VMSR Program.
The final order ``Microbiology Devices; Reclassification of Human
Immunodeficiency Virus Serological Diagnostic and Supplemental Tests
and Human Immunodeficiency Virus Nucleic Acid Diagnostic and
Supplemental Tests'' (May 16, 2022; 87 FR 29661) established special
controls for certain Human Immunodeficiency Virus (HIV) serological
diagnostic and supplemental tests (21 CFR 866.3956) and for HIV nucleic
acid tests (NATs) diagnostic and supplemental tests (21 CFR 866.3957)
to support their classification into class II, including submission of
a log of all complaints annually for a period of 5 years following FDA
clearance of a traditional premarket notification (510(k)) submission
for these devices. (Information collections associated with premarket
notification (510(k)) are approved under OMB control number 0910-0120.)
Earlier notification through the submission of the complaint log
enables us to more promptly determine whether public health issues have
been adequately addressed. The agency would not otherwise evaluate the
kind of complaint information that would be included in the log until
an FDA inspection, which typically occurs less frequently than
annually. Implementing these specific reporting measures as part of the
special controls for these devices is necessary to provide a reasonable
assurance of safety and effectiveness for HIV diagnostic and
supplemental tests subject to the reclassification order.
Provisions of part 4 subpart B (21 CFR part 4, subpart B), provide
that when information regarding an event that involves a death or
serious injury, or an adverse event, associated with the use of a
combination product is received by the product sponsor, the information
must be provided to the other constituent part applicant(s) no later
than 5 calendar days after receipt. Part 4 also explains how and where
to submit reports and provides for associated recordkeeping. These
requirements are described in part 803.
Respondents are manufacturers and importers of medical devices and
device user facilities. Device user facility means a hospital,
ambulatory surgical facility, nursing home, outpatient diagnostic
facility, or outpatient treatment facility as defined in Sec. 803.3,
which is not a physician's office (also defined in Sec. 803.3).
Respondents are also sponsors (manufacturers) of device-led combination
products (see part 4, subpart B). Respondents also include
manufacturers of HIV diagnostic and supplemental test devices.
Manufacturer and importer respondents submit reports electronically
using FDA Form 3500A (approved under OMB control number 0910-0291) via
either ``eSubmitter'' for low-volume reporters or Health Level Seven
(HL7) Individual Case Study Report (ICSR) (HL7 ICSR) for high-volume
reporters. User facilities reporting under Sec. Sec. 803.30 and 803.32
have the option of electronic or paper-based reporting. User facility
annual reporting under Sec. 803.33 is paper-based, using form FDA
3419. Instructions for submitting the information are available in
Sec. Sec. 803.11, 803.12, and 803.20, and on FDA's public website at
<a href="https://www.fda.gov/medical-devices/postmarket-requirements-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities">https://www.fda.gov/medical-devices/postmarket-requirements-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities</a> (links to forms FDA 3500A and FDA 3419 are provided on
the web page).
In the Federal Register of May 8, 2025 (90 FR 19490), FDA published
a 60-day notice requesting public comment on the proposed collection of
information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
[[Page 35700]]
Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Number of Total annual Average burden Total hours operating and
Activity/CFR section FDA Form No.\2\ respondents responses per responses per response \1\ maintenance
respondent costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR Part 803 ``Medical Device Reporting,'' 21 CFR Part 4, subpart B ``Postmarketing Safety Reporting for Combination Products,'' and FDA
notification; order granting alternative entitled, ``Medical Devices and Device-led Combination Products; Voluntary Malfunction Summary Reporting
Program for Manufacturers''
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exemptions--803.19................ .................... 28 1 28 1 28 ..............
User Facility Reporting--803.30 FDA 3500A........... 296 18.99 5,621 0.35 1,967 ..............
and 803.32.
User Facility Annual Reporting-- FDA 3419............ 82 1 82 1 82 ..............
803.33.
Importer Reporting, Death and FDA 3500A........... 144 1,034.604 148,983 1 148,983 ..............
Serious Injury--803.40 and 803.42.
Manufacturer Reporting--803.50 FDA 3500A........... 1,871 1,240.1887 2,320,393 0.10 232,039 $18,710
through 803.53.
Voluntary Malfunction Summary FDA 3500A........... 44 56.88 2,503 0.10 250 ..............
Reporting Program.
Supplemental Reports--803.56...... FDA 3500A........... 1,501 684.604 1,027,591 0.10 102,759 ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR 866.3956 ``Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test'' and 866.3957 ``Human immunodeficiency virus (HIV)
nucleic acid (NAT) diagnostic and/or supplemental test''
--------------------------------------------------------------------------------------------------------------------------------------------------------
Special controls: submission of .................... 10 1 10 3 30 ..............
complaint log;
866.3956(b)(1)(iii) and
866.3957(b)(1)(iii).
-----------------------------------------------------------------------------------------------
Total......................... .................... .............. .............. 3,505,211 .............. 486,138 18,710
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Numbers are rounded.
\2\ Form FDA 3500A is approved under OMB Control No. 0910-0291. This ICR includes burden only for MDR submissions.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity/21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping \2\
----------------------------------------------------------------------------------------------------------------
MDR Procedures--803.17.......... 1,871 1 1,871 3.3 6,174
MDR Files--803.18............... 1,871 1 1,871 1.5 2,807
-------------------------------------------------------------------------------
Total....................... .............. .............. 3,742 .............. 8,981
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Numbers are rounded.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure \2\
----------------------------------------------------------------------------------------------------------------
Importer Reporting, Death and 144 1,034.60 148,983 0.35 52,144
Serious Injury--803.40 and
803.42.......................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Numbers are rounded.
Upon review of this information collection, we updated the burden
estimates based on internal data regarding MDRs received by FDA for
fiscal year (FY) 2024. Device-led combination product reporting and
disclosure under part 4, subpart B, are included in the burden
estimates. Based on FY2024 data for ``Manufacturer Reporting 803.50
through 803.53,'' we estimate 1,871 respondents and 2,320,393 total
annual responses.
The FDA notification and order granting alternative entitled,
``Medical Devices and Device-led Combination Products; Voluntary
Malfunction Summary Reporting Program for Manufacturers'' grants an
alternative under Sec. 803.19 to permit manufacturer reporting of
certain device malfunctions in summary form on a quarterly basis. The
associated FDA guidance entitled ``Voluntary Malfunction Summary
Reporting (VMSR) Program for Manufacturers'' (August 2024) is intended
to help manufacturers better understand and use the VMSR Program. The
Voluntary Malfunction Summary Reporting (VMSR) Program does not apply
to reportable death or serious injury events, which are required to be
reported to FDA within the mandatory 30-calendar day timeframe, under
Sec. Sec. 803.50 and 803.52, or within the 5-work day timeframe under
Sec. 803.53. Thus, if a manufacturer participating in the program
becomes aware of information reasonably suggesting that a device it
markets may have caused or contributed to a death or serious injury,
then the manufacturer must submit an individual MDR for that event
because it involves a reportable death or serious injury. We expect
that a summary report will take approximately the same amount of time
to prepare as an individual report.
[[Page 35701]]
Unlike manufacturers, device user facilities are not required to
submit malfunction reports under part 803. User facilities, such as
hospitals or nursing homes, are required to submit MDRs to FDA and/or
the manufacturer only for reportable death or serious injury events.
(See section 519(b) of the FD&C Act; 21 CFR 803.30(a).) We believe that
by permitting alternative reporting for certain devices, the VMSR
Program may reduce burden on respondents who elect to participate and
are otherwise subject to mandatory requirements.
Special controls established in the final order ``Microbiology
Devices; Reclassification of Human Immunodeficiency Virus Serological
Diagnostic and Supplemental Tests and Human Immunodeficiency Virus
Nucleic Acid Diagnostic and Supplemental Tests'' to support the class
II classification of certain HIV serological diagnostic and
supplemental tests (21 CFR 866.3956) and for HIV NATs diagnostic and
supplemental tests (21 CFR 866.3957) require the submission of a log of
all complaints annually for a period of 5 years following FDA clearance
of a traditional premarket notification (510(k)) submission for these
devices. (Information collections associated with premarket
notification (510(k)) are approved under OMB control number 0910-0120.)
Although manufacturers of HIV serological diagnostic and supplemental
tests and HIV NAT diagnostic and supplemental tests are already
required to maintain complaint files and to review and evaluate
complaints for these devices under 21 CFR 820.198, special controls are
necessary to provide a reasonable assurance of safety and effectiveness
of these devices. (Information collections associated with Quality
System requirements under 21 CFR part 820 are approved under OMB
control number 0910-0073.) We estimate it will take a manufacturer
approximately 3 hours annually to review their existing records,
prepare the complaint log, and submit to FDA.
We assume a cost of $10 associated with the payment of an annual
fee to maintain e-certification will apply to each respondent. We
estimate a total operating and maintenance cost of $18,710 ($10 x 1,871
respondents).
Since the last OMB approval, we have adjusted the respondent and
response estimates based on FY 2024 data. We also adjusted the Average
Burden per Response for ``Exemptions--803.19'' and ``Importer
Reporting, Death and Serious Injury--803.40 and 803.42'' from 0.1 hour
to 1 hour to correct an error introduced in a previous request for
extension of this information collection. These adjustments have
resulted in an overall increase of 1,527,443 total responses, and a
corresponding increase of 323,806 total burden hours.
We are revising this information collection to add the FDA guidance
entitled ``Voluntary Malfunction Summary Reporting (VMSR) Program for
Manufacturers'' (August 2024; <a href="https://www.fda.gov/media/163692/download">https://www.fda.gov/media/163692/download</a>), which is intended to help manufacturers better understand
and use the VMSR Program. The guidance does not affect the burden
estimates.
Dated: July 23, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-14230 Filed 7-28-25; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on July 29, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.