Notice2023-01849
Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices
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Published
January 30, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
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<title>Federal Register, Volume 88 Issue 19 (Monday, January 30, 2023)</title>
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[Federal Register Volume 88, Number 19 (Monday, January 30, 2023)]
[Notices]
[Pages 5888-5891]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#a3f3f1e2f0d7c2c5c5e3c5c7c28dcbcbd08dc4ccd5"><span class="__cf_email__" data-cfemail="104042514364717676507674713e7878633e777f66">[email protected]</span></a>.
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 <a href="https://www.fda.gov/medical-devices/premarket-approval-pma/pma-historical-background">https://www.fda.gov/medical-devices/premarket-approval-pma/pma-historical-background</a> 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
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-information-about-pediatric-uses-medical-devices">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-information-about-pediatric-uses-medical-devices</a>.
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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/form-fda-3674-certifications-accompany-drug-biological-product-and-device-applicationssubmissions">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/form-fda-3674-certifications-accompany-drug-biological-product-and-device-applicationssubmissions</a>, 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 <a href="https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program">https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program</a> 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
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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.
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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
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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
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