```

[Federal Register Volume 89, Number 243 (Wednesday, December 18, 2024)]
[Notices]
[Pages 102910-102911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29955]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 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 0910-0138. 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, 
[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.

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 https://www.fda.gov/about-fda/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 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                       21 CFR part; activity                            Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   860.123; supporting data for reclassification petitions.....              12                1               12              497            5,964
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
```