[Federal Register Volume 88, Number 34 (Tuesday, February 21, 2023)]
[Notices]
[Pages 10517-10519]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

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

FOR FURTHER INFORMATION CONTACT: 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, 
[email protected].

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

[[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:
     Device name;
     Establishment registration number, if applicable, of the 
owner or operator submitting the premarket notification submission;
     Device class;
     Action taken under section 514 of the FD&C Act (21 U.S.C. 
360d) for performance standards; and
     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.
     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.
     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.
     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).
     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).
     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.
     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.
     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.
                                    --------------------------------------------------------------------------------------------------------------------
    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


