Notice2025-16853
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Accessories
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
September 3, 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
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<title>Federal Register, Volume 90 Issue 168 (Wednesday, September 3, 2025)</title>
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[Federal Register Volume 90, Number 168 (Wednesday, September 3, 2025)]
[Notices]
[Pages 42591-42593]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16853]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-P-0100]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Device
Accessories
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 October 3, 2025.
[[Page 42592]]
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 0910-0823. 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, 10 a.m.-12 p.m.,
11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#cb9b998a98bfaaadad8badafaae5a3a3b8e5aca4bd"><span class="__cf_email__" data-cfemail="3f6f6d7e6c4b5e59597f595b5e1157574c11585049">[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 Accessories
OMB Control Number 0910-0823--Extension
FDA's guidance document entitled ``Medical Device Accessories--
Describing Accessories and Classification Pathways'' (December 2017)
(available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-accessories-describing-accessories-and-classification-pathways">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-accessories-describing-accessories-and-classification-pathways</a>) is intended to provide guidance to
industry and FDA staff about the regulation of accessories to medical
devices, to describe FDA's policy concerning the classification of
accessories, and to discuss the application of this policy to devices
that are commonly used as accessories to other medical devices. In
addition, the guidance explains what devices FDA generally considers an
``accessory'' and describes the processes under section 513(f)(6) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(f)(6)) (FD&C
Act) to allow requests for risk- and regulatory control-based
classification of accessories.
The FDA Reauthorization Act of 2017 (FDARA) changed how FDA
regulates medical device accessories. Specifically, section 707 of
FDARA added section 513(f)(6) of the FD&C Act to the statute and
requires that FDA, upon request, classify existing and new accessories
notwithstanding the classification of any other device with which such
accessory is intended to be used. This means that the classification of
an accessory may not be the same as its parent device, depending on the
risks of the accessory when used as intended and the level of
regulatory controls necessary for reasonable assurance of safety and
effectiveness of the accessory. Until an accessory is distinctly
classified, its existing classification will continue to apply. This
provision does not preclude a manufacturer from submitting a De Novo
request for an accessory under section 513(f)(2) of the FD&C Act.
Depending on an accessory's regulatory history, there are different
submission types, tracking mechanisms, and deadlines:
(1) Existing accessory types are those that have been identified in
a classification regulation or granted marketing authorization as part
of a 510(k) (section 510(k) of the FD&C Act (21 U.S.C. 360(k),
premarket application (PMA) (section 515 of the FD&C Act (21 U.S.C.
360e), or De Novo (section 513(f)(2) of the FD&C Act) request (approved
under OMB control numbers 0910-0120, 0910-0231, and 0910-0844,
respectively). Manufacturers with marketing authorization for an
existing accessory may request appropriate classification through a new
stand-alone premarket submission (Existing Accessory Request). Upon
request, FDA is required to meet with a manufacturer or importer to
discuss the appropriate classification of an existing accessory prior
to submitting a written request. Existing Accessory Requests will be
initially tracked as ``Q-submissions'' (approved under OMB control
number 0910-0756). FDA has a statutory deadline of 85 calendar days to
respond to an Existing Accessory Request.
(2) New accessory types are those that have not been granted
marketing authorization as part of a 510(k), PMA, or De Novo request.
Manufacturers may include new accessories in a 510(k) or PMA with the
parent device (New Accessory Request). New Accessory Requests will have
the same deadline as the 510(k) or PMA. Therefore, new accessory types
should follow the applicable Medical Device User Fee Amendments of 2017
deadline for the parent submission. The decision for New Accessory
Requests will be separate from the decision for the marketing
application.
For both Existing and New Accessory Requests, manufacturers must
request proper classification of their accessory in the submission and
include draft special controls, if requesting classification into class
II. The processes that we use to classify an accessory will be like
those used for De Novo requests. If FDA grants the Accessory Request,
FDA must issue an order establishing a new classification regulation
for the accessory type. If FDA denies the Accessory Request, FDA must
issue a letter with a detailed description and justification for our
determination.
In the Federal Register of June 16, 2025 (90 FR 25326), 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 \1\
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Number of Total
Activity Number of responses per annual Average burden Total
respondents respondent responses per response hours
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Existing Accessory Request................... 10 1 10 40 400
New Accessory Request........................ 5 1 5 40 200
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Total.................................... ............ .............. .......... .............. 600
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 42593]]
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. 2025-16853 Filed 9-2-25; 8:45 am]
BILLING CODE 4164-01-P
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