Notice2025-08086
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting
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Published
May 8, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collections associated with requirements for medical device reporting for user facilities, manufacturers, importers, and distributors of medical devices.
Full Text
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<title>Federal Register, Volume 90 Issue 88 (Thursday, May 8, 2025)</title>
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[Federal Register Volume 90, Number 88 (Thursday, May 8, 2025)]
[Notices]
[Pages 19490-19494]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-08086]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0419]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Reporting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed revision of an existing collection of information, and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on information collections associated with
requirements for medical device reporting for user facilities,
manufacturers, importers, and distributors of medical devices.
DATES: Either electronic or written comments on the collection of
information must be submitted by July 7, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 7, 2025. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to
[[Page 19491]]
the docket unchanged. Because your comment will be made public, you are
solely responsible for ensuring that your comment does not include any
confidential information that you or a third party may not wish to be
posted, such as medical information, your or anyone else's Social
Security number, or confidential business information, such as a
manufacturing process. Please note that if you include your name,
contact information, or other information that identifies you in the
body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2025-N-0419 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Device Reporting.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR/2015/09/18/pdf/2015/23389.pdf">https://www.govinfo.gov/content/pkg/FR/2015/09/18/pdf/2015/23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
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#a4f4f6e5f7d0c5c2c2e4c2c0c58accccd78ac3cbd2"><span class="__cf_email__" data-cfemail="0c5c5e4d5f786d6a6a4c6a686d2264647f226b637a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed revision of an existing collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Medical Device Reporting--21 CFR Part 803
OMB Control Number 0910-0437--Revision
This information collection supports Food and Drug Administration
(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
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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).
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
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Total
Number of Number of Total annual Average burden Total hours Total capital operating and
Activity/CFR section FDA form Number respondents responses per responses per response \1\ costs maintenance
respondent costs
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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''
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Exemptions--803.19............................ ................................ 28 1 28 1 28 .............. ..............
User Facility Reporting--803.30 and 803.32.... FDA 3500A....................... 296 18.99 5,621 0.35 1,967 .............. ..............
User Facility Annual Reporting--803.33........ FDA 3419........................ 82 1 82 1 82 .............. ..............
Importer Reporting, Death and Serious Injury-- FDA 3500A....................... 144 1,034.604 148,983 1 148,983 .............. ..............
803.40 and 803.42.
Manufacturer Reporting--803.50 through 803.53. FDA 3500A....................... 1,871 1,240.1887 2,320,393 0.10 232,039 .............. $18,710
Voluntary Malfunction Summary Reporting FDA 3500A....................... 44 56.88 2,503 0.10 250 .............. ..............
Program.
Supplemental Reports--803.56.................. FDA 3500A....................... 1,501 684.604 1,027,591 0.10 102,759 .............. ..............
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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''
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Special controls: submission of complaint log; ................................ 10 1 10 3 30 .............. ..............
866.3956(b)(1)(iii) and 866.3957(b)(1)(iii).
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Total..................................... ................................ .............. .............. 3,505,201 .............. 486,138 .............. 18,710
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\1\ Numbers are rounded.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
Activity/21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping \2\
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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
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Total....................... .............. .............. 3,742 .............. 8,981
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\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\
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Number of
Activity/21 CFR section Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure \2\
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Importer Reporting, Death and 144 1,034.60 148,983 0.35 52,144
Serious Injury--803.40 and
803.42.......................
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\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.
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
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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 1,374,708 total responses, and a
corresponding increase of 262,681 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 estimated
burden estimates.
Dated: May 5, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-08086 Filed 5-7-25; 8:45 am]
BILLING CODE 4164-01-P
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