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[Federal Register Volume 89, Number 249 (Monday, December 30, 2024)]
[Notices]
[Pages 106512-106513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31014]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-2149]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; De Novo 
Classification Process (Evaluation of Automatic Class III Designation)

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 29, 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 0910-0844. 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, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[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.

De Novo Classification Process (Evaluation of Automatic Class III 
Designation)--21 CFR Part 860, Subpart D

OMB Control Number 0910-0844--Revision

    This information collection supports FDA regulations and 
information collection discussed in associated guidance. Sections 
201(h), 513(a) and (f), 701(a), and 704 of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 321(h), 360c(a) and (f), 371(a), and 
374) establish a comprehensive system for the regulation of medical 
devices intended for human use. Section 513(f)(2) of the FD&C Act 
provides for a ``De Novo'' classification process, most recently 
amended by section 3101 of the 21st Century Cures Act (Pub. L. 114-
255). The final rule ``Medical Device De Novo Classification Process'' 
(86 FR 54826), established part 860, subpart D (21 CFR part 860, 
subpart D) (Sec. Sec.  860.200 through 860.260) to implement provisions 
in section 513(f)(2) of the FD&C Act. These regulations govern format 
and content elements for De Novo device classification requests, as 
well as withdrawal of the requests, and explain FDA procedures for 
acceptance, review, and granting or denying a request.
    FDA's guidance for industry and FDA staff, ``De Novo Classification 
Process (Evaluation of Automatic Class III Designation)'', provides 
guidance on the process for the submission and review of a De Novo 
classification request under section 513(f)(2) of the FD&C Act, also 
known as the De Novo classification process. This process provides a 
pathway to class I or class II classification for medical devices for 
which general controls or general and special controls provide a 
reasonable assurance of safety and effectiveness, but for which there 
is no legally marketed predicate device.
    In addition to regulatory requirements set forth in part 860, 
subpart D, the guidance document entitled ``Acceptance Review for De 
Novo Classification Requests'' communicates our thinking on criteria 
set out in Sec.  860.230, in assessing whether a De Novo request should 
be accepted for substantive review. The guidance document includes an 
``Acceptance Checklist'' to assist respondents in this regard.
    The guidance document ``Electronic Submission Template for Medical 
Device De Novo Requests,'' provides the standards for the submission of 
De Novo requests by electronic format, a timetable for establishment of 
these standards, and criteria for waivers of and exemptions from the 
requirements to meet a statutory requirement. This guidance is also 
intended to represent one of several steps in meeting FDA's commitment 
to the development of electronic submission templates to serve as 
guided submission preparation tools for industry to improve submission 
consistency and enhance efficiency in the review process.
    The collections of information described by this notice are 
necessary to satisfy the previously mentioned statutory requirements 
for administration of this voluntary submission program. FDA uses the 
information to evaluate whether a medical device may be reclassified 
from class III into class I or II and, if applicable, to determine the 
general and/or special controls necessary to sufficiently regulate the 
medical device. Respondents to this information collection are private 
sector or other for-profit businesses.
    In the Federal Register of May 29, 2024 (89 FR 46402), 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
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  21 CFR part 860, subpart D;                      Number of
    information collection         Number of     responses per   Total annual    Average burden     Total hours
           activity               respondents     respondent       responses      per response
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Sec.  Sec.   860.210, 860.220,              79               1              79  182.............          14,378
 860.230; De Novo requests--
 format, content, and
 acceptance elements.
Sec.   860.230; FDA acceptance              79               1              79  ................  ..............
 of request (GFI Acceptance
 Checklist; Appendix A) \1\.

[[Page 106513]]

 
Sec.   860.250; withdrawal of                5               1               5  0.17 (10 mins.).               1
 request.
                                                                                                 ---------------
    Total.....................  ..............  ..............  ..............  ................          14,379
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\1\ FDA assumes activities associated with review of the Acceptance Checklist are included in burden for
  submission of requests captured in row 1.

    Our estimated burden for the information collection reflects an 
overall increase of 2,002 hours and a corresponding increase of 11 
responses. We attribute this adjustment to an increase in the number of 
submissions we received over the last few years. Since the publication 
of the 60-day notice, we issued the guidance document entitled 
``Electronic Submission Template for Medical Device De Novo Requests'' 
(August 23, 2024, 89 FR 68166; https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-medical-device-de-novo-requests) and are including it in this 
information collection. Given that all submissions were previously 
received electronically and the ability to voluntarily submit De Novo 
requests using eSTAR was included in the previous information 
collection request (ICR), inclusion of the guidance in this ICR is not 
expected to impact the estimated burden.

    Dated: December 13, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-31014 Filed 12-27-24; 8:45 am]
BILLING CODE 4164-01-P
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