[Federal Register Volume 90, Number 166 (Friday, August 29, 2025)]
[Notices]
[Pages 42251-42253]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-16630]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1330]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget
[[Page 42252]]
(OMB) for review and clearance under the Paperwork Reduction Act of
1995.
DATES: Submit written comments (including recommendations) on the
collection of information by September 29, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. 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 0910-0625. 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,
[email protected].
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.
Electronic Submission of Medical 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, B, C, and 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).
In the Federal Register of June 20, 2025 (90 FR 26304), 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:
Table 1--Estimated Annual Reporting Burden
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Number of Average
21 CFR part FDA form number Number of responses per Total annual burden per Total hours
respondents respondent responses response
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807.20(a)(5) \2\ Initial 2,219 1 2,219 1.75 3883
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 1 1 1 1 1
for 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)...
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 4,080 1 4,080 0.25 1,020
listing information (outside
of annual listing requirement
period): Voluntary reporting
of 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).......
[[Page 42253]]
807.41(a) \3\ Identification 2,955 1 2,955 0.5 1,478
of initial importers defined
in 21 CFR 807.3(g) by foreign
establishments (FDA 3673)....
807.41(b) \3\ Identification 3,234 1 3,234 0.5 1,617
of 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 Burden1
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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 22,338 1 22,338 .25 5,585
Officers, 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 34,526
responses. 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.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-16630 Filed 8-28-25; 8:45 am]
BILLING CODE 4164-01-P