Notice2026-18529
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Tracking
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 11, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) 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 requirements for the tracking of medical devices.
Full Text
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<title>Federal Register, Volume 91 Issue 175 (Friday, September 11, 2026)</title>
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[Federal Register Volume 91, Number 175 (Friday, September 11, 2026)]
[Notices]
[Pages 57893-57895]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-18529]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-9350]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Tracking
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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
requirements for the tracking of medical devices.
DATES: Either electronic or written comments on the collection of
information must be submitted by November 10, 2026.
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 November 10, 2026. 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
[[Page 57894]]
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-2026-N-9350 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Device Tracking.''
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 Barrett, 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#e5b5b7a4b691848383a5838184cb8d8d96cb828a93"><span class="__cf_email__" data-cfemail="633331223017020505230507024d0b0b104d040c15">[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.
Medical Device Tracking--21 CFR Part 821
OMB Control Number 0910-0442--Extension
Section 519(e)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360i(e)(1)) provides that FDA may require by order that a
manufacturer adopt a method for tracking a class II or III medical
device, if the device meets one of the three following criteria: (1)
the failure of the device would be reasonably likely to have serious
adverse health consequences, (2) the device is intended to be implanted
in the human body for more than 1 year (referred to as a ``tracked
implant''), or (3) the device is life-sustaining or life-supporting
(referred to as a ``tracked l/s-l/s device'') and is used outside a
device user facility. Tracked device information is collected to
facilitate identifying the current location of medical devices and
patients possessing those devices, to the extent that patients permit
the collection of identifying information. Manufacturers and FDA (where
necessary) use the data to: (1) expedite the recall of distributed
medical devices that are dangerous or defective and (2) facilitate the
timely notification of patients or licensed practitioners of the risks
associated with the medical device. In addition, applicable regulations
in 21 CFR part 821 (21 CFR 821.1 through 821.60) include provisions
for: (1) exemptions and variances; (2) system and content requirements
for tracking; (3) obligations of persons other than device
manufacturers, e.g., distributors; (4) records and inspection
requirements; (5) confidentiality; and (6) record retention
requirements.
Respondents to the collection of information are medical device
manufacturers, importers, and distributors of tracked implants or
tracked l/s-l/s devices used outside a device user facility.
Distributors include multiple and final distributors, including
hospitals. We currently estimate 22,000 potential respondents.
FDA estimates the burden of this collection of information as
follows:
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Table 1--Estimated Annual Reporting Burden
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Number of
Activity/21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Discontinuation of business-- 1 1 1 1 1
821.1(d).......................
Exemption or variance--821.2 and 1 1 1 1 1
821.30(e)......................
Notification of failure to 2 2 4 1 4
comply--821.25(d)..............
Multiple distributor data-- 1 1 1 1 1
821.30(c)(2)...................
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Total....................... .............. .............. .............. .............. 7
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Table 2--Estimated Annual Recordkeeping Burden
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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
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Tracking information--821.25(a). 13 1 13 76 988
Record of tracking data-- 13 46,260 601,380 1 601,380
821.25(b)......................
Standard operating procedures-- 13 1 13 63 819
821.25(c) \1\..................
Manufacturer data audit-- 13 1,124 14,612 1 14,612
821.25(c)(3)...................
Multiple distributor data and 22,000 1 22,000 1 22,000
distributor tracking records--
821.30(c)(2) and (d)...........
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Total....................... .............. .............. .............. .............. 639,799
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\1\ One-time burden.
Table 3--Estimated Annual Third-Party Disclosure Burden
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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
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Acquisition of tracked 22,000 1 22,000 1 22,000
devices and final
distributor data--821.30(a)
and (b).....................
Multiple distributor data and 1,100 1 1,100 1 1,100
distributor tracking
records--821.30(c)(2) and
(d).........................
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Total.................... .............. ................. .............. .............. 23,100
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Our estimated burden for the information collection reflects an
overall increase of 47,526 hours and a corresponding increase of 47,389
responses/records. We attribute this adjustment to an increase in the
number of submissions we received over the last few years.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-18529 Filed 9-10-26; 8:45 am]
BILLING CODE 4164-01-P
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