Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Approval of Medical Devices, 18552-18554 [2023-06485]
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Federal Register / Vol. 88, No. 60 / Wednesday, March 29, 2023 / Notices
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new drug application (sNDA) 017031/S–
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Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committees. All electronic
and written submissions submitted to
the Docket (see ADDRESSES) on or before
April 25, 2023, will be provided to the
committees. Oral presentations from the
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Eastern Time on May 9, 2023. Those
individuals interested in making formal
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speak is greater than can be reasonably
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hearing session. The contact person will
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notify interested persons regarding their
request to speak by April 18, 2023.
For press inquiries, please contact the
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: March 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–06524 Filed 3–28–23; 8:45 am]
BILLING CODE 4164–01–P
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.
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.
SUMMARY:
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
ADDRESSES:
PO 00000
Frm 00041
Fmt 4703
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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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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/pmahistorical-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
E:\FR\FM\29MRN1.SGM
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ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 60 / Wednesday, March 29, 2023 / Notices
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/
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providing-information-about-pediatricuses-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/regulatoryinformation/search-fda-guidancedocuments/form-fda-3674-certificationsaccompany-drug-biological-productand-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
PO 00000
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Sfmt 4703
18553
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 onetime 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 60day notice requesting public comment
on the proposed collection of
information.
We estimate the information
collection as follows:
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Federal Register / Vol. 88, No. 60 / Wednesday, March 29, 2023 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity/21 CFR part/section or FD&C act section
Total
annual
responses
Average
burden per
response
Total hours
Premarket Approval Submissions (‘‘traditional’’ preparation; eCopy submission):
21 CFR Part 814, Premarket Approval of Medical Devices
Subpart A—General:
Research conducted outside the United States (814.15(b)) ........
Subpart B—Premarket Approval Application (PMA):
PMA application (814.20) .............................................................
Information on clinical investigations conducted outside the
United States (814.20(b)(6)(ii)(C)).
PMA amendments and resubmitted PMAs (814.37(a)–(c) and
(e)).
PMA supplements (814.39(a)) ......................................................
Special PMA supplement—changes being affected (814.39(d))
30-day notice (814.39(f)) ..............................................................
Subtotal Parts A and B ..........................................................
Subpart C—FDA Action on a PMA:
Panel of experts request (814.44 and 515(c)(3) of the FD&C
Act).
Subpart E—Postapproval Requirements:
Postapproval requirements (814.82(a)(9)) ...................................
Periodic reports (814.84(b)) ..........................................................
Total Subpart E ..............................................................
20
1
20
2 ......................................
40
40
10
1
1
40
10
654.6 ...............................
0.5 (30 minutes) .............
26,184
5
1,356
1
1,356
167 ..................................
226,452
762
75
1,181
........................
1
1
1
........................
762
75
1,181
........................
0.5911 (35.5 minutes) ....
6 ......................................
16 ....................................
.........................................
45,048
450
18,896
317,075
1
1
1
30 ....................................
30
121
764
1
1
121
764
135 ..................................
10 ....................................
16,335
7,640
........................
........................
........................
.........................................
24,005
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’’
Certification to accompany PMA submissions (Form FDA 3674) .......
FD&C Act section 515A Pediatric Uses of Devices:
Pediatric information in a PMA, PDP, or PMA supplement .........
Pediatric use information outside approved indication .................
40
1
40
0.75 (45 minutes) ...........
30
944
800
1
1
944
800
2.10 .................................
0.5 (30 minutes) .............
1,984
400
Subtotal ..................................................................................
Premarket Approval Submissions (eSTAR preparation; eCopy submission):
eSTAR setup ................................................................................
1,744
1
1,744
.........................................
2,384
30
1
30
0.08 (5 minutes) .............
2
Total .......................................................................................
........................
........................
........................
.........................................
343,496
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
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.
Activity/21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total
hours
Maintenance of records (814.82(a)(5) and (6)) ...................
552
1
552
17
9,384
1 There
ddrumheller on DSK120RN23PROD with NOTICES1
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
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
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Jkt 259001
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.
PO 00000
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Dated: March 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–06485 Filed 3–28–23; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
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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).
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.
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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
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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 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]
BILLING CODE 4164-01-P
