Notice2024-29955
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices
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
December 18, 2024
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 89 Issue 243 (Wednesday, December 18, 2024)</title>
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[Federal Register Volume 89, Number 243 (Wednesday, December 18, 2024)]
[Notices]
[Pages 102910-102911]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-29955]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2844]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Reclassification
Petitions for Medical Devices
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 January 17, 2025.
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 0910-0138. Also include the FDA docket
number found in brackets in the heading of this document.
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,
<a href="/cdn-cgi/l/email-protection#134341524067727575537577723d7b7b603d747c65"><span class="__cf_email__" data-cfemail="f5a5a7b4a681949393b5939194db9d9d86db929a83">[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.
Reclassification Petitions for Medical Devices
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.
[[Page 102911]]
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 <a href="https://www.fda.gov/about-fda/cdrh-transparency/reclassification">https://www.fda.gov/about-fda/cdrh-transparency/reclassification</a> 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 Sec. 860.123(b).
In the Federal Register of July 9, 2024 (89 FR 56390), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received, but it was not
related to this information collection.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR part; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Sec. 860.123; supporting data for reclassification petitions..... 12 1 12 497 5,964
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\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 (Sec. 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: December 11, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-29955 Filed 12-17-24; 8:45 am]
BILLING CODE 4164-01-P
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