Notice2023-12489
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification of Devices
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Published
June 12, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) 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 (PRA).
Full Text
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<title>Federal Register, Volume 88 Issue 112 (Monday, June 12, 2023)</title>
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[Federal Register Volume 88, Number 112 (Monday, June 12, 2023)]
[Notices]
[Pages 38063-38065]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-12489]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-1889]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Premarket
Notification of Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 (PRA).
DATES: Submit written comments (including recommendations) on the
collection of information by July 12, 2023.
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 0910-0120. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#acfcfeedffd8cdcacaeccac8cd82c4c4df82cbc3da"><span class="__cf_email__" data-cfemail="237371627057424545634547420d4b4b500d444c55">[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.
Premarket Notification of Devices
OMB Control Number 0910-0120--Revision
This information collection helps support implementation of
statutory provisions that govern premarket clearance of devices.
Section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 360(k)) and implementing regulations in part 807, subpart E
(21 CFR part 807, subpart E), establish premarket notification
procedures. Persons who intend to market a medical device, for which a
premarket approval application (PMA) is not required, must submit a
premarket notification to FDA, unless the device is exempt from 510(k)
requirements and does not exceed the limitations of exemptions of the
device classification regulations, at least 90 days before proposing to
begin the introduction, or delivery for introduction into interstate
commerce, for commercial distribution of a device intended for human
use. Based on the information provided in the notification, FDA must
determine whether the new device is substantially
[[Page 38064]]
equivalent to a legally marketed device. If a device is determined to
be not substantially equivalent to a legally marketed device, it must
have an approved PMA, product development protocol, humanitarian device
exemption (HDE), request for an evaluation of automatic class III
designation (De Novo request), or be reclassified into class I or class
II before being marketed. The information collection also helps support
section 510(l) of the FD&C Act, which provides for exemption from
premarket notification.
The following instruments are included in the information
collection:
<bullet> Form FDA 3514, ``CDRH Premarket Review Submission Cover
Sheet''
<bullet> Form FDA 3881, ``Indications for Use''
<bullet> Voluntary eSTAR Program Interactive PDF Form and instructional
web page
<bullet> Form FDA 4062, ``Electronic Submission Template and Resource
(eSTAR)'' (for non-In Vitro Diagnostic (IVD) 510(k) submissions)
<bullet> Form FDA 4078, ``Electronic Submission Template and Resource
(eSTAR)'' (for In Vitro Diagnostic (IVD) 510(k) submissions)
We are revising the information collection to include Form FDA
3674, ``Certification of Compliance, Under 42 U.S.C., 282(j)(5)(B),
with Requirements of <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>.'' Under applicable
authorities, applications under sections 505, 515, or 520(m) of the
FD&C Act (21 U.S.C. 355, 360e, or 360j(m)), or under section 351 of the
Public Health Service Act (42 U.S.C. 262), or submission of a report
under section 510(k) of the FD&C Act, must be accompanied by a
certification. Where available, such certification must include the
appropriate National Clinical Trial numbers.
The information collection also includes an ``Acceptance
Checklist.'' As discussed in the guidance document ``Refuse to Accept
Policy for 510(k)s'' (April 2022), available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks</a>, we believe the checklist can be a helpful resource for
510(k) submitters and may simplify preparation of the 510(k).
Similarly, the guidance document ``Recognition and Withdrawal of
Voluntary Consensus Standards'' (September 2020), available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recognition-and-withdrawal-voluntary-consensus-standards">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recognition-and-withdrawal-voluntary-consensus-standards</a>, communicates
procedures followed by the Center for Devices and Radiological Health
(CDRH) when requests for recognition of a voluntary consensus standard
for medical products are received. The guidance document outlines
principles for recognizing a standard wholly, partly, or not at all, as
well as reasons and rationales for withdrawing a standard. Section 514
of the FD&C Act (21 U.S.C. 360d) allows FDA to recognize consensus
standards developed by international and national organizations for use
in satisfying portions of device premarket review submissions,
including premarket notifications or other requirements. We publish and
update the list of recognized standards regularly at <a href="https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm">https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm</a>. As instructed in the guidance document, any interested
party may submit a request for recognition of a standard by mail
directed to the CDRH Standards Program (i.e., paper copy) or
electronically via email.
For efficiency of Agency operations, we are also revising the
information to include activities associated with section 520(b) of the
FD&C Act, governing custom devices. Regulations in 21 CFR 812.3 define
a custom device and implementing regulations in 21 CFR 807.85 provide
for exemption from premarket notification. Section 520(b) of the FD&C
Act also provides for the issuance of guidance. The guidance document
entitled, ``Custom Device Exemption'' (September 2014), and available
for download at <a href="https://www.fda.gov/media/89897/download">https://www.fda.gov/media/89897/download</a>, explains how
FDA interprets provisions in section 520(b)(2)(B) of the FD&C Act,
describes what information should be submitted in a Custom Device
Annual Report (``annual report''), and provides recommendations on how
to submit an annual report for devices distributed under the custom
device exemption.
Finally, we discuss the guidance document entitled, ``Transition
Plan for Medical Devices That Fall Within Enforcement Policies Issued
During the Coronavirus Disease 2019 (COVID-19) Public Health
Emergency,'' announced in the Federal Register of March 27, 2023 (88 FR
18153), which describes a phased approach intended to help avoid
disruption in device supply and help facilitate compliance with
applicable legal requirements. The recommendations discussed in the
guidance document result in the one-time collection of information
intended to ensure an orderly and transparent transition from temporary
policies established during the COVID-19 public health emergency to
normal operations. Because the information collection recommendations
apply to specific medical devices already in distribution, we believe
the information discussed is appropriately characterized as
nonstandardized followup designed to clarify responses to approved
collections of information (i.e., plans for compliance with applicable
requirements unique to that distributed device). We therefore believe
the activity constitutes the collection of non-identical and/or
followup information, as defined under 5 CFR 1320.3. At the same time,
we expect some degree of fluctuation in future submissions under part
807, subpart E, as a result of implementation of the medical device
transition plan.
In the Federal Register of February 21, 2023 (88 FR 10517), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received. However, since
publication of our 60-day notice, we have adjusted our previous
estimate to include burden associated with Form FDA 3674 (submission
certification), as well as custom device reporting currently included
in OMB control number 0910-0767 and discussed in the Federal Register
of March 13, 2023 (88 FR 15410).
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity and 21 CFR part/section Form FDA No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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21 CFR Part 807, Subpart E, Premarket Notification Procedures
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510(k) submission (807 subpart E)..... 3881 3,800 1 3,800 79.25........................... 301,150
Summary cover sheet (807.87).......... 3514 1,906 1 1,906 0.5 (30 minutes)................ 953
Status request (807.90(a)(3))......... .............. 1 1 1 0.25 (15 minutes)............... 1
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510(k) summary (807.92)............... .............. 2,725 1 2,725 4............................... 10,900
510(k) statement (807.93)............. .............. 215 1 215 10.............................. 2,150
510(k) submission (807 subpart E)-- 4062, 4078 100 1 100 40.............................. 4,000
using eSTAR format.
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Guidance Document Recommendations
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Submitting information associated with .............. 9 1 9 1............................... 9
requests for recognition of a
voluntary consensus standard.
Annual reporting for custom devices .............. 34 1 34 40.............................. 1,360
under 520(b) of the FD&C Act.
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``Form FDA 3674--Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions''
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Certification to accompany 510(k) 3674 3,800 1 3,800 0.75 (45 minutes)............... 2,850
submissions.
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Electronic Submission Template and Resource (eSTAR)
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eSTAR setup--one-time burden.......... .............. 80 1 80 0.08 (5 minutes)................ 6
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Total............................. .............. .............. .............. 12,670 ................................ 323,379
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\1\ There are no capital costs, or operating and maintenance costs, associated with the information collection.
Both the regulations in part 807, subpart E and the associated
guidance documents prescribe specific format and content elements
necessary for FDA action on submissions. Based on recent trends, an
estimated 3,800 submissions are expected each year. Our administrative
and technical staff, who are familiar with the requirements for
submission of premarket notifications, estimate that it takes an
average of 79.25 hours to prepare a submission. Because the PRA defines
a recordkeeping requirement to include a requirement to report those
records to the Federal government, we account for burden associated
with preparing, transmitting, and responding to followup requests from
FDA for supplemental information in our estimate. We expect to receive
approximately 100 510(k) submissions via eSTAR per year and estimate
that eSTAR submissions will each require 40 hours to complete. In
addition, based on a recent review of submissions, we estimate 1,906
summary cover sheets will be received annually. We assume 30 minutes
are needed to complete the summary cover sheet. We further estimate
that 9 respondents will submit information pertaining to a request for
recognition of a voluntary standard and that the activity requires an
average of 1 hour. We also account for a one-time setup burden of 5
minutes for an estimated 80 new eSTAR users annually.
As a result of adding burden previously included under OMB control
numbers 0910-0616 (submission certification element) and 0910-0767
(custom device exemptions), we have adjusted our burden upward. We have
also made nominal adjustments on individual provisions to reflect
expected fluctuations in submissions. Cumulatively, these actions
result in an overall increase of 3,671 hours and a corresponding
increase of 4,210 responses annually.
Dated: June 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-12489 Filed 6-9-23; 8:45 am]
BILLING CODE 4164-01-P
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