Notice2025-11312
Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submissions of Medical Device Registration and Listing
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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
June 20, 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 extension 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 collection associated with electronic submission of medical device registration and listing.
Full Text
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<title>Federal Register, Volume 90 Issue 117 (Friday, June 20, 2025)</title>
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[Federal Register Volume 90, Number 117 (Friday, June 20, 2025)]
[Notices]
[Pages 26304-26306]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-11312]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No.FDA-2025-N-1330]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Electronic Submissions of Medical Device Registration
and Listing
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 extension 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 collection associated with
electronic submission of medical device registration and listing.
DATES: Either electronic or written comments on the collection of
information must be submitted by August 19, 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 August 19, 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 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-1330 for ``Electronic Submission of Medical Device
Registration and Listing.'' 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
[[Page 26305]]
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#efbfbdaebc9b8e8989af898b8ec187879cc1888099"><span class="__cf_email__" data-cfemail="67373526341306010127010306490f0f1449000811">[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 extension 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.
Electronic Submission of Medial Device Registration and Listing--21 CFR
Part 807, Subparts A Through D
OMB Control Number 0910-0625--Extension
This information collection supports FDA statutes and regulations.
Under section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360) and part 807, subparts A through D (21 CFR part
807, subparts A through D), medical device establishment owners and
operators are required to electronically submit establishment
registration and device listing information. Complete and accurate
registration and listing information is necessary to accomplish a
number of statutory and regulatory objectives, such as: (1)
Identification of establishments producing marketed medical devices,
(2) identification of establishments producing a specific device when
that device is in short supply or is needed for national emergency, (3)
facilitation of recalls for devices marketed by owners and operators of
device establishments, (4) identification and cataloguing of marketed
devices, (5) administering post marketing surveillance programs for
devices, (6) identification of devices marketed in violation of the
law, (7) identification and control of devices imported into the
country from foreign establishments, (8) and scheduling and planning
inspections of registered establishments under section 704 of the FD&C
Act (21 U.S.C. 374).
Respondents to this information collection are owners or operators
of establishments that engage in the manufacturing, preparation,
propagation, compounding, or processing of a device or devices, who
must register their establishments and submit listing information for
each of their devices in commercial distribution. Notwithstanding
certain exceptions, foreign device establishments that manufacture,
prepare, propagate, compound, or process a device that is imported or
offered for import into the United States must also comply with the
registration and listing requirements. The number of respondents is
based on data from the FDA Unified Registration and Listing System
(FURLS).
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
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Number of
21 CFR part FDA form number Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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807.20(a)(5) \2\ Initial 2,219 1 2,219 1.75 3,883
Submittal of Manufacturer
Information by Initial
Importers (FDA 3673)...........
807.20(a)(5) \3\ Annual 2,219 1 2,219 0.1 222
Submittal of Manufacturer
Information by Initial
Importers (FDA 3673)...........
807.21(a) \2\ Creation of 8,876 1 8,876 0.5 4,438
electronic system account (FDA
3673)..........................
807.21(b) \3\ Annual Request for 1 1 1 1 1
Waiver from Electronic
Registration & Listing.........
807.21(b) \2\ Initial Request 1 1 1 1 1
for Waiver from Electronic
Registration & Listing.........
807.22(a) \2\ Initial 2,106 1 2,106 1 2,106
Registration & Listing (FDA
3673)..........................
807.22(b)(1) \3\ Annual 30,280 1 30,280 0.5 15,140
Registration (FDA 3673)........
807.22(b)(2) \3\ Other updates 3,906 1 3,906 0.5 1,953
of Registration (FDA 3673).....
[[Page 26306]]
807.22(b)(3) \3\ Annual Update 28,925 1 28,925 0.5 14,463
of Listing Information (FDA
3673)..........................
807.22(b)(4) Changes to listing
information (outside of annual
listing requirement period):
Voluntary reporting of 4,080 1 4,080 0.25 1,020
transfer of 510(k)
clearance in FURLS (outside
of annual listing
requirement period)........
Submission of 510(k) 2,033 1 2,033 4 8,132
transfer documentation when
more than one party lists
the same 510(k)............
807.26(e) \3\ Labeling & 1 1 1 1 1
Advertisement Submitted at FDA
Request........................
807.34(a) \2\ Initial 1 1 1 1 1
Registration & Listing when
Electronic Filing Waiver
Granted........................
807.34(a) \3\ Annual 1 1 1 1 1
Registration & Listing when
Electronic Filing Waiver
granted........................
807.40(b)(2) \3\ Annual Update 3,410 1 3,410 0.5 1,705
of US Agent Information (FDA
3673)..........................
807.40(b)(3) \3\ US Agent 1,535 1 1,535 0.25 384
Responses to FDA Requests for
Information (FDA 3673).........
807.41(a) \3\ Identification of 2,955 1 2,955 0.5 1,478
initial importers defined in 21
CFR 807.3(g) by foreign
establishments (FDA 3673)......
807.41(b) \3\ Identification of 3,234 1 3,234 0.5 1,617
other importers (defined in 21
CFR 807.3(x) and (y) that
facilitate import by foreign
establishments (FDA 3673)......
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Total....................... .............. .............. .............. .............. 56,546
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\1\ Totals are rounded to the nearest whole number.
\2\ One Time Burden--Firm only provides initially.
\3\ Recurring Burden--Firm is required to review annually.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
21 CFR part Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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807.25(d) \2\ List of Officers, 22,338 1 22,338 .25 5,585
Directors & Partners...........
807.26 \2\ Labeling & 17,032 4 68,128 .5 34,064
Advertisements Available for
Review.........................
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Total....................... .............. .............. .............. .............. 39,649
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Recurring burden--Firm is required to keep records.
Our estimated burden for the information collection reflects an
overall decrease of 17,637 hours and a corresponding decrease of 34,530
responses/records. Burden estimates are based on recent registration
and listing information collected from establishments registering for
the first time (initial registration) and establishments re-
registering. We attribute this adjustment to a decrease in the number
of submissions we received over the last approval period.
Dated: June 13, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11312 Filed 6-18-25; 8:45 am]
BILLING CODE 4164-01-P
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