Notice2023-03520
Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification Procedures
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Published
February 21, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) 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 medical device premarket notification (510(k)).
Full Text
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<title>Federal Register, Volume 88 Issue 34 (Tuesday, February 21, 2023)</title>
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[Federal Register Volume 88, Number 34 (Tuesday, February 21, 2023)]
[Notices]
[Pages 10517-10519]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-03520]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0804]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Premarket Notification Procedures
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 medical device premarket notification (510(k)).
DATES: Either electronic or written comments on the collection of
information must be submitted by April 24, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. 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 April 24, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received 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 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-2013-N-0804 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Premarket Notification
Procedures.'' 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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#c696948795b2a7a0a086a0a2a7e8aeaeb5e8a1a9b0"><span class="__cf_email__" data-cfemail="2b7b796a785f4a4d4d6b4d4f4a05434358054c445d">[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
[[Page 10518]]
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 Notification--21 CFR Part 807, Subpart E
OMB Control Number 0910-0120--Revision
Section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360(k)) and implementing regulations in part 807 (21
CFR part 807, subpart E) require a premarket notification submission
(510(k)) at least 90 days before the introduction, or delivery for
introduction into interstate commerce, for commercial distribution of a
device intended for human use. Based on the information provided in the
notification, FDA determines whether the new device is substantially
equivalent to a legally marketed device, as defined in Sec.
807.92(a)(3). If the device is determined to be not substantially
equivalent to a legally marketed device, it must have an approved
premarket approval application (PMA), product development protocol,
humanitarian device exemption (HDE), request for an evaluation of
automatic class III designation (De Novo request), or be reclassified
into class I or class II before being marketed (see OMB control numbers
0910-0231, 0910-0332, 0910-0844, and 0910-0138). FDA makes the final
decision of whether a device is substantially equivalent or not
substantially equivalent.
Section 807.81 governs when a 510(k) is required. A 510(k) is
required to be submitted by a person who is: (1) introducing a device
to the market for the first time; (2) introducing a device into
commercial distribution for the first time by a person who is required
to register; or (3) introducing or reintroducing a device that is
significantly changed or modified in design, components, method of
manufacturer, or the intended use that could affect the safety and
effectiveness of the device.
Section 807.87 also lists the information required in each
premarket notification (510(k)) submission. Each submission should
contain the following information:
<bullet> Device name;
<bullet> Establishment registration number, if applicable, of the
owner or operator submitting the premarket notification submission;
<bullet> Device class;
<bullet> Action taken under section 514 of the FD&C Act (21 U.S.C.
360d) for performance standards; and
<bullet> Proposed labels, labeling, and advertisements sufficient
to describe the device, its intended use, and the directions for its
use. Where applicable, photographs or engineering drawings should be
supplied.
<bullet> A statement indicating that the device is similar to and/
or different from other products of a comparable type in commercial
distribution, accompanied by data to support the statement.
<bullet> For devices that have undergone a significant change or
modification, data to show that the manufacturer has considered
consequences and effects that a change, modification, or new use might
have on the safety and effectiveness of the device.
<bullet> A 510(k) summary as described in Sec. 807.92 or a 510(k)
statement as described in Sec. 807.93 (burden included in Sec. Sec.
807.92 and 807.93, respectively).
<bullet> A financial certification or disclosure statement or both,
as required by 21 CFR part 54 (see OMB control number 0910-0396,
Financial Disclosure by Clinical Investigators).
<bullet> For submissions claiming substantial equivalence to a
device which has been classified into class III that was introduced or
delivered for introduction into interstate commerce for commercial
distribution before December 1, 1990, and for which no final regulation
requiring premarket approval has been issued under section 515(b) of
the FD&C Act (21 U.S.C. 360e(b)), a summary of the types of safety and
effectiveness problems associated with the type of devices being
compared and a citation to the information upon which the summary is
based (class III summary). The 510(k) submitter shall also certify that
a reasonable search of all information known or otherwise available
about class III device and other similar legally marketed devices has
been conducted (class III certification), as described in Sec. 807.94.
<bullet> A statement that the submitter believes, to the best of
his or her knowledge, that all data and information submitted in the
premarket notification are truthful and accurate and that no material
fact has been omitted.
<bullet> Any additional information regarding the device requested
by the Commissioner of Food and Drugs that is necessary for the
Commissioner to make a finding as to whether or not the device is
substantially equivalent to a device in commercial distribution.
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the FD&C Act.
Amended section 514 of the FD&C Act allows FDA to recognize consensus
standards developed by international and national organizations for use
in satisfying portions of device premarket review submissions including
510(k) or other requirements. FDA has published and regularly updated
the list of recognized standards since enactment of FDAMA and has
allowed 510(k) submitters to certify conformance to recognized
standards to meet the requirements of Sec. 807.87.
Section 745A(b) of the FD&C Act (21 U.S.C. 379k-1(b)), amended by
section 207 of the FDA Reauthorization Act of 2017 (Pub. L. 115-52),
requires that submissions for devices under section 510(k), among other
submission types, be submitted in electronic format specified by FDA.
In addition, in the Medical Device User Fee Amendments of 2017
Commitment Letter from the Secretary of Health and Human Services to
Congress, FDA committed to developing ``electronic submission templates
that will serve as guided submission preparation tools for industry to
improve submission consistency and enhance efficiency in the review
process.'' The Electronic Submission Template and Resource (eSTAR) is
such an electronic submission template for 510(k) submissions to
facilitate the preparation of submissions in electronic format.
FDA estimates the burden of this collection of information as
follows:
[[Page 10519]]
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity and 21 CFR part/section Form No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses \2\ \1\
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510(k) submission (807 subpart E).. FDA 3881............. 3,800 1 3,800 79.25....................... 301,150
Summary cover sheet (807.87)....... FDA 3514............. 1,906 1 1,906 0.5 (30 minutes)............ 953
Status request (807.90(a)(3))...... ..................... 1 1 1 0.25 (15 minutes)........... 1
510(k) summary (807.92)............ ..................... 2,725 1 2,725 4........................... 10,900
510(k) statement (807.93).......... ..................... 215 1 215 10.......................... 2,150
510(k) submission (807 subpart E)-- FDA 4062, FDA 4078... 100 1 100 40.......................... 4,000
via eSTAR.
eSTAR setup--one-time burden....... ..................... 80 1 80 0.08 (5 minutes)............ 6
Request for recognition of a ..................... 9 1 9 1........................... 9
voluntary consensus standard.
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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 510(k) FDA 3674............. 3,800 1 3,800 0.75 (45 minutes)........... 2,850
submissions.
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Total.......................... ..................... .............. .............. .............. ............................ 322,019
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.
Summary Cover Sheet Form
Form FDA 3514 assists respondents in categorizing administrative
510(k) information for submission to FDA. This form also assists
respondents in categorizing information for other FDA medical device
programs such as PMAs, investigational device exemptions, De Novo
requests, HDEs, etc.
Status Request
Under Sec. 807.90(a)(3), inquiries regarding a 510(k) submission
should be in writing and sent to one of the addresses in Sec.
807.90(a).
510(k) Summary and 510(k) Statement
Under Sec. 807.87(h), each 510(k) submitter must include in the
510(k) either a summary of the information in the 510(k) as required by
Sec. 807.92 (510(k) summary) or a statement certifying that the
submitter will make available upon request the information in the
510(k) with certain exceptions as per Sec. 807.93 (510(k) statement).
Electronic Submission Template and Resource (eSTAR)
The Electronic Submission Template and Resource (eSTAR) is such an
electronic submission template for 510(k) submissions to facilitate the
preparation of submissions in electronic format.
Request for Recognition of a Voluntary Consensus Standards
FDA has published and regularly updated the list of recognized
standards since enactment of FDAMA and has allowed 510(k) submitters to
certify conformance to recognized standards to meet the requirements of
Sec. 807.87.
Certification To Accompany PMA Submissions (Section 402(j) of the PHS
Act)
The information required under section 402(j)(5)(B) of the PHS Act,
recommended in the FDA guidance document ``Form FDA 3674--
Certifications To Accompany Drug, Biological Product, and Device
Applications/Submissions,'' and associated with the HHS regulations at
42 CFR part 11 (published on September 20, 2016, see 81 FR 64981), is
to be submitted with applications currently submitted to FDA under 21
CFR part 814.
Section 402(j)(5)(B) of the PHS Act, requires that a certification
accompany human drug, biological, and device product submissions made
to FDA. Specifically, at the time of submission of an application 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, or submission of a
report under section 510(k) of the FD&C Act, such application or
submission must be accompanied by a certification that all applicable
requirements of section 402(j) of the FD&C Act have been met. Where
available, such certification must include the appropriate National
Clinical Trial numbers. We have made Form FDA 3674 available for
submitting the certification.
Our estimated burden for the information collection reflects an
overall increase of 2,850 hours and a corresponding increase of 3,800
responses. This information collection is being revised to add the
estimated burden for ``Certification to accompany 510(k) submissions''
from OMB control number 0910-0616 to this burden estimate.
Dated: February 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03520 Filed 2-17-23; 8:45 am]
BILLING CODE 4164-01-P
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