[Federal Register Volume 88, Number 19 (Monday, January 30, 2023)]
[Notices]
[Pages 5888-5891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01849]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0187]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Premarket Approval of Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on information collection associated with 
premarket approval of medical devices.

DATES: Submit either electronic or written comments on the collection 
of information by March 31, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before March 31, 2023. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of March 31, 2023. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note

[[Page 5889]]

that if you include your name, contact information, or other 
information that identifies you in the body of your comments, that 
information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2023-N-0187 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Premarket Approval of Medical 
Devices.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

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: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Premarket Approval of Medical Devices

OMB Control Number 0910-0231--Revision

    This information collection supports implementation of statutory 
and regulatory requirements that govern premarket approval of medical 
devices. Premarket approval (PMA) is the FDA process of scientific and 
regulatory review to evaluate the safety and effectiveness of Class III 
medical devices. Class III devices are those that support or sustain 
human life, are of substantial importance in preventing impairment of 
human health, or which present a potential, unreasonable risk of 
illness or injury. Due to the level of risk associated with Class III 
devices, FDA has determined that general and special controls alone are 
insufficient to assure the safety and effectiveness of Class III 
devices. Therefore, these devices require a premarket approval (PMA) 
application under section 515 of the FD&C Act (21 U.S.C. 360e) in order 
to obtain marketing approval. Please note that PMA requirements apply 
differently to preamendments devices, postamendments devices, and 
transitional class III devices and some Class III preamendment devices 
may require a Class III 510(k). See the PMA Historical Background web 
page at https://www.fda.gov/medical-devices/premarket-approval-pma/pma-historical-background for additional information. Section 515A of the 
FD&C Act (21 U.S.C. 360e-1) governs pediatric uses of devices.
    The PMA is the most stringent type of device marketing application 
required by FDA. Applicants must receive FDA approval of a PMA 
application prior to marketing the device. PMA approval is based on a 
determination that the PMA contains sufficient valid scientific 
evidence to assure that the device is safe and effective for its 
intended use(s). Respondents to the information collection are PMA 
applicants, or persons who own the rights, or otherwise have authorized 
access, to the data and other information to be submitted in support of 
FDA approval. This person may be an individual, partnership, 
corporation, association, scientific or academic establishment, 
government agency or organizational unit, or other legal entity. The 
applicant is often the inventor/developer and ultimately the 
manufacturer. A Class III device that fails to meet PMA requirements is 
considered to be

[[Page 5890]]

adulterated under section 501(f) of the FD&C Act (21 U.S.C. 351(f)) and 
may not be marketed.
    FDA regulations in part 814 (21 CFR part 814) implement section 515 
and 515A of the FD&C Act and establish procedures for the premarket 
approval of medical devices intended for human use, including the 
submission of information concerning use in pediatric patients. 
Regulations in part 814, subpart A (Sec. Sec.  814.1 to 814.19) set 
forth general provisions pertaining to the confidentiality of data and 
information submitted to FDA in a PMA, research conducted outside the 
United States, service of orders, and product development protocols. 
Provisions in part 814, subparts B and C (Sec. Sec.  814.20 to 814.47) 
establish format and content elements that must be included in an 
application, explain submission and review schedules, and address the 
withdrawal and temporary suspension of a PMA. Postapproval 
requirements, including reports required under 21 CFR part 803 (medical 
device reporting), are covered in regulations in part 814, subpart E 
(Sec. Sec.  814.80 to 814.84). Burden attributable to information 
collection associated with regulations in part 814, subpart H 
(Sec. Sec.  814.100 to 814.126) pertaining to Humanitarian Use Devices 
is currently approved in OMB control number 0910-0332.
    For operational efficiency, we are revising the information 
collection to include burden that may be associated with 
recommendations found in the Agency guidance document entitled, 
``Providing Information about Pediatric Uses of Medical Devices'' (May 
2014), currently approved in OMB control number 0910-0748. The guidance 
document describes how to compile and submit the readily available 
pediatric use information required under section 515A of the FD&C Act. 
The guidance document is available for download from our website at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-information-about-pediatric-uses-medical-devices.
    Relatedly, we are revising the information collection to include 
burden that may be associated with the submission of information on 
pediatric use of medical devices under section 515A of the FD&C Act, 
also currently approved in OMB control number 0910-0748. Section 
515A(a) of the FD&C Act requires applicants who submit information to 
include readily available information providing a description of any 
pediatric subpopulations that suffer from the disease or condition that 
the device is intended to treat, diagnose, or cure, and the number of 
affected pediatric patients. This information allows FDA to track the 
number of approved devices for which there is a pediatric subpopulation 
that suffers from the disease or condition that the device is intended 
to treat, diagnose, or cure and the review time for each such device 
application.
    We are also revising the information collection to include burden 
applicable to implementing requirements under section 402(j)(5)(B) of 
the Public Health Service (PHS) Act (42 U.S.C. 282(j)(5)(b)), and set 
forth in regulations at 42 CFR part 11 (see 81 FR 64981, September 21, 
2016). Specifically, 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 PHS 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. We have developed Form FDA 3674 
(``Certifications to Accompany Drug, Biological Product, and Medical 
Device Applications/Submissions''), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/form-fda-3674-certifications-accompany-drug-biological-product-and-device-applicationssubmissions, for respondents to submit the requisite 
information.
    Respondents can make single submissions in an electronic format 
that includes eCopies, submissions submitted on CD, DVD, or flash drive 
and mailed to FDA and eSubmissions, submissions created using an 
electronic submission template (e.g., ``electronic Submission Template 
and Resource'' (eSTAR)). Consistent with our authority in section 
745A(b) of the FD&C Act (21 U.S.C. 379k-1(b)), and performance goals 
found in our current Medical Device User Fee Amendments Commitment 
Letter, we developed eSTAR for use through the Center for Devices and 
Radiological Health Customer Collaboration Portal. We use eSTAR as a 
tool to facilitate the preparation of submissions in electronic format 
(available on FDA's website at https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program and identified as 
Form FDA 4062 ``Electronic Submission Template and Resource (eSTAR)'' 
(for Non-In Vitro Diagnostic submissions) and form FDA 4078 
``Electronic Submission Template and Resource (eSTAR)'' (for In Vitro 
Diagnostic submissions)). We believe respondents' use of eSTAR will 
significantly reduce burden attendant to application submissions by 
providing a uniform format for requisite elements and by enhancing user 
interface through the use of modernized technology.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                 Number of
     Activity/21 CFR or FD&C Act section         Number of     responses per   Total annual      Average  burden per  response (hours)      Total hours
                                                respondents     respondent       responses
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                                     Premarket Approval Submissions (``traditional'' preparation; eCopy submission)
                                                 21 CFR Part 814, Premarket Approval of Medical Devices
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Subpart A--General:
    Research conducted outside the United                 20               1              20  2.........................................              40
     States (814.15(b)).
Subpart B--Premarket Approval Application
 (PMA):
    PMA application (814.20)................              40               1              40  654.6.....................................          26,184
    Information on clinical investigations                10               1              10  0.5 (30 minutes)..........................               5
     conducted outside the United States
     (814.20(b)(6)(ii)(C)).
    PMA amendments and resubmitted PMAs                1,356               1           1,356  167.......................................         226,452
     (814.37(a)-(c) and (e)).
    PMA supplements (814.39(a)).............             762               1             762  0.983 (59.11 minutes).....................          45,048
    Special PMA supplement--changes being                 75               1              75  6.........................................             450
     affected (814.39(d)).
    30-day notice (814.39(f))...............           1,181               1           1,181  16........................................          18,896
        Subtotal Parts A and B..............  ..............  ..............  ..............  ..........................................         317,075
Subpart C--FDA Action on a PMA:
    Panel of experts request (814.42 and                   1               1               1  30........................................              30
     515(c)(3) of the FD&C Act).

[[Page 5891]]

 
Subpart E--Postapproval Requirements:
    Postapproval requirements (814.82(a)(9))             121               1             121  135.......................................          16,335
    Periodic reports (814.84(b))............             764               1             764  10........................................           7,640
                                             -----------------------------------------------------------------------------------------------------------
        Total Subpart E.....................  ..............  ..............  ..............  ..........................................          24,005
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 42 CFR part 11, Clinical Trials Registration and Results Information Submission, subparts D and E; and FDA Guidance ``Form FDA 3674--Certifications To
                                        Accompany Drug, Biological Product, and Device Applications/Submissions''
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Certification to accompany PMA submissions                40               1              40  0.75 (45 minutes).........................              30
 (Form FDA 3674).
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                                                    FD&C Act section 515A Pediatric Uses of Devices:
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Pediatric information in a PMA, PDP, or PMA              944               1             944  2.10......................................            1984
 supplement.
Pediatric use information outside approved               800               1             800  0.5 (30 minutes)..........................             400
 indication.
                                             -----------------------------------------------------------------------------------------------------------
        Subtotal............................           1,744               1           1,744  ..........................................           2,384
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                                          Premarket Approval Submissions (eSTAR preparation; eCopy submission):
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eSTAR setup.................................              30               1              30  0.08 (5 minutes)..........................               2
                                             -----------------------------------------------------------------------------------------------------------
            Total...........................  ..............  ..............  ..............  ..........................................         343,496
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimate is based on the annual rate of receipt of PMA 
submissions, including PDPs and PMA supplements, for fiscal years 2019 
through 2021 and our expectation of submissions to come in the next few 
years. We also account for referrals of PMAs to a panel for review, as 
provided for under Sec.  814.44(a). FDA may refer the PMA to a panel on 
its own initiative, and will do so upon request of an applicant, unless 
FDA determines that the application substantially duplicates 
information previously reviewed by a panel. We have adjusted our 
figures to reflect an overall decrease, which we attribute to 
respondents' use of modernized submission technologies including eSTAR. 
At the same time, we include in our estimate an initial burden 
attributable to respondents who need to set up an eSTAR account for the 
first time.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                         Number of                      Average  burden
                      Activity/21 CFR section                           Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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Maintenance of records (814.82(a)(5) and (a)(6))...................             552                1              552               17            9,384
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The regulations require the maintenance of records, which are used 
to trace patients, and the organization and indexing of records into 
identifiable files to ensure a device's continued safety and 
effectiveness. These records are required of all applicants who have an 
approved PMA. Currently there are 815 active PMAs that could be subject 
to these requirements, based on FDA data, and approximately 33 new PMAs 
are approved each year. We estimate our annual recordkeeping burden 
based on an average of 552 PMA holders. The applicant determines which 
records should be maintained during product development to document 
and/or substantiate the device's safety and effectiveness. Records 
required under 21 CFR part 820 may be relevant to a PMA review and may 
be submitted as part of an application. In individual instances, 
records may be required as conditions of approval to ensure the 
device's continuing safety and effectiveness.
    Cumulatively, our adjustments reflect only a slight increase to the 
estimated burden for the information collection.

    Dated: January 25, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01849 Filed 1-27-23; 8:45 am]
BILLING CODE 4164-01-P