[Federal Register Volume 88, Number 112 (Monday, June 12, 2023)]
[Notices]
[Pages 38063-38065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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 0910-0120. 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, 
[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.

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:

 Form FDA 3514, ``CDRH Premarket Review Submission Cover 
Sheet''
 Form FDA 3881, ``Indications for Use''
 Voluntary eSTAR Program Interactive PDF Form and instructional 
web page
 Form FDA 4062, ``Electronic Submission Template and Resource 
(eSTAR)'' (for non-In Vitro Diagnostic (IVD) 510(k) submissions)
 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 ClinicalTrials.gov.'' 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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks, 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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recognition-and-withdrawal-voluntary-consensus-standards, 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. 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 https://www.fda.gov/media/89897/download, 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

[[Page 38065]]

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


