4164-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2844]
Agency Information Collection Activities; Proposed Collection; Comment Request;
Reclassification Petitions for Medical Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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 reclassification of medical devices.
DATES: Either electronic or written comments on the collection of information must be
submitted by [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE
FEDERAL REGISTER].
ADDRESSES: You may submit comments as follows. Please note that late, untimely filed
comments will not be considered. The https://www.regulations.gov electronic filing system will
accept comments until 11:59 p.m. Eastern Time at the end of [INSERT DATE 60 DAYS
AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. 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:

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Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for
submitting comments. Comments submitted electronically, including attachments, to
https://www.regulations.gov 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
https://www.regulations.gov.

•

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:
•

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.

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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-2024-N-2844

for “Agency Information Collection Activities; Proposed Collection; Comment Request;
Reclassification Petitions for Medical Devices.” 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 https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
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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 https://www.regulations.gov. 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:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and

written/paper comments received, go to https://www.regulations.gov 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: JonnaLynn Capezzuto, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301-796-3794, PRAStaff@fda.hhs.gov.

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.
Reclassification Petitions for Medical Devices--21 CFR Part 860, Subpart C
OMB Control Number 0910-0138--Extension
This information collection helps support implementation of statutory provisions found in
sections 513(e) and (f), 514(b), 515(b), and 520(l) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360c(e) and (f), 21 U.S.C. 360d(b), 21 U.S.C. 360e((b), and 21 U.S.C.
360j(l)) pertaining to the reclassification of medical devices. Specifically, the FD&C Act
establishes three tiers of regulatory control for medical devices, by establishing three classes of
medical devices, and requiring that all devices be classified into one of these three classes. The

classification of a device depends upon the degree of regulatory control necessary to provide a
reasonable assurance of the safety and effectiveness of the device. The three tiers of regulatory
control are: (1) Class I--general controls, subject to sections 501 adulteration, 502 misbranding,
510 registration, 516 banned devices, 518 notification and other remedies, 519 records and
reports, and 520 general provisions of the FD&C Act; (2) Class II--performance standards; and
(3) Class III--premarket approval.
Implementing regulations in 21 CFR part 860, subpart C (parts 860.120 through 860.136)
provide that any person may petition for reclassification of a device from any class to any other
class, and prescribe requisite format and content elements for reclassification petitions submitted
to the Agency. We also provide information on our website at https://www.fda.gov/aboutfda/cdrh-transparency/reclassification regarding medical device reclassification, which may
serve as a helpful resource to respondents.
FDA is responsible for reviewing petitions for reclassification and determining whether
the subject device will be reclassified. In some instances, FDA also submits such petitions to
one of its medical device advisory panels for review and recommendations. FDA’s decision
regarding the reclassification of a device is based primarily upon the information contained in the
petition. Respondents to the information collection are private sector, for-profit businesses. We
have not identified reclassification petitions as a type of submission we are currently prepared to
accept electronically. Submission instructions, including addresses, are provided in
§ 860.123(b).
FDA estimates the burden of this collection of information as follows:
21 CFR Part; Activity

Table 1.--Estimated Annual Reporting Burden1
No. of
No. of Responses
Total Annual
Respondents
per Respondent
Responses
12
1
Average Burden
per Response
Total
Hours
5,964

§ 860.123; supporting
data for reclassification
petitions
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Reclassification petitions must be submitted as set forth in the applicable regulations,
which provide for the submission of an original and two copies (§ 860.123(b)(4)). Each petition

must include supporting data to show why reclassification of the device type will provide
reasonable assurance of the safety and effectiveness of the device type. The principal data in
such a petition will typically be reports of clinical trials.
Our estimated burden for the information collection reflects an increase of 6 responses
and a corresponding increase of 2,982 hours. We attribute this adjustment to an increase in the
number of submissions we received over the last few years.
Dated: July 3, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.

[FR Doc. 2024-14995 Filed: 7/8/2024 8:45 am; Publication Date: 7/9/2024]