Document ID: FDA-2023-N-0187-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Approval of Medical Devices
Posted Date: 2023-03-29T04:00Z

[Federal Register Volume 88, Number 60 (Wednesday, March 29, 2023)]
[Notices]
[Pages 18552-18554]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06485]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) 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 April 28, 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 0910-0231. 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 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 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 
application (PMA) under section 515 of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 360e) to obtain marketing approval. 
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 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

[[Page 18553]]

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 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 (21 CFR 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 
(PDPs). Provisions in part 814, subparts B and C (21 CFR 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 
(21 CFR 814.80 to 814.84). Burden attributable to information 
collection associated with regulations in part 814, subpart H (21 CFR 
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.
    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. The 
guidance document describes a phased-in 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 continued compliance 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 21 CFR 814.20, 
as a result of implementation of the medical device transition plan.
    In the Federal Register of January 30, 2023 (88 FR 5888), we 
published a 60-day notice requesting public comment on the proposed 
collection of information.
    We estimate the information collection as follows:

[[Page 18554]]

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                 Number of
  Activity/21 CFR part/section or FD&C act       Number of     responses per   Total  annual         Average  burden per  response          Total hours
                   section                      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  0.5911 (35.5 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 (814.44 and                   1               1               1  30........................................              30
     515(c)(3) of the FD&C Act).
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).
FD&C Act section 515A Pediatric Uses of
 Devices:
    Pediatric information in a PMA, PDP, or              944               1             944  2.10......................................           1,984
     PMA supplement.
    Pediatric use information outside                    800               1             800  0.5 (30 minutes)..........................             400
     approved indication.
                                             -----------------------------------------------------------------------------------------------------------
        Subtotal............................           1,744               1           1,744  ..........................................           2,384
Premarket Approval Submissions (eSTAR
 preparation; eCopy submission):
    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 21 CFR 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.

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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 (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.

    Dated: March 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06485 Filed 3-28-23; 8:45 am]
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