[Federal Register Volume 84, Number 249 (Monday, December 30, 2019)]
[Notices]
[Pages 71958-71961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28098]


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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

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

[[Page 71959]]

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: Submit either electronic or written comments on the collection 
of information by February 28, 2020.

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 February 28, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of February 28, 2020. 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:
     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.'' 
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.
     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.

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 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--Extension
    Section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 360(k)) and the implementing regulation under part 807 
(21 CFR part 807, subpart E) require a person who intends to market a 
medical device to submit a 510(k) submission to FDA at least 90 days 
before proposing to begin 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

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notification, FDA must determine whether the new device is 
substantially equivalent to a legally marketed device, as defined in 
Sec.  807.92(a)(3) (21 CFR 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 states 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 lists the information 
required in each 510(k).
    Form FDA 3514, a summary cover sheet form, 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.
    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 
(21 U.S.C. 360d). 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 updated regularly 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.
    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).
    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).
    Section 745A(b) of the FD&C Act, amended by section 207 of the FDA 
Reauthorization Act of 2017 (FDARA) (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 (MDUFA IV) Commitment 
Letter from the Secretary of Health and Human Services to Congress,\1\ 
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.
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    \1\ See 163 CONG. REC. S4729-S4736 (daily ed. August 2, 2017) 
(Food and Drug Administration User Fee Reauthorization), also 
available at https://www.fda.gov/media/102699/download.
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    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                               Number of
     Activity and 21 CFR part/section         Form number      Number of     responses per   Total annual    Average burden per response    Total hours
                                                              respondents     respondent       responses                 \2\                    \2\
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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.........................             953
Status request (807.90(a)(3)).............  ..............               1               1               1  0.25........................               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)--via            FDA 4062             100               1             100  40..........................           4,000
 eSTAR.
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eSTAR setup--(one-time burden)............  ..............              80               1              80  0.08 (5 minutes)............               6
                                                                                                                                         ---------------
    Total.................................  ..............  ..............  ..............  ..............  ............................         319,160
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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.

    Upon review of this information collection, we have made the 
following changes:
     We have updated the burden estimate consistent with new 
provisions in Sec.  807.87(j) regarding ``Human Subject Protection; 
Acceptance of Data from Clinical Investigations for Medical Devices'' 
(83 FR 7366; February 21, 2018) (approved under OMB control number 
0910-0741). Section 807.87 was amended to address requirements for 
510(k) submissions supported by clinical data. For clinical 
investigations conducted in the United States, submitters are required 
to submit a statement as described in Sec.  807.87(j)(1). For clinical 
investigations conducted outside the United States, submitters are 
required to submit the information as described in Sec.  807.87(j)(2). 
Consistent with our estimate in OMB control number 0910-0741, this 
revision increases our burden estimate for a

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510(k) submission by 15 minutes per submission.
     We corrected the burden table to include a line for the 
``510(k) Summary'' under Sec.  807.92. This section was inadvertently 
removed from the previous version of the information collection request 
(ICR).
     We are making available Form FDA 3881 ``Indications for 
Use'' that respondents include as part of a medical device 510(k). The 
information provided via the form is already approved under this ICR. 
The form does not ask for new information and does not bear on the 
underlying program or on the hour or cost burden associated with the 
information collection, rather it provides a fillable, 508-compliant 
format for respondents to use for the ``Indications for Use'' portion 
of their 510(k) submission.
     We updated the guidance ``Refuse to Accept Policy for 
510(k)s'' to explicitly recommend providing an Acceptance Checklist in 
the 510(k) submission. The guidance previously provided the checklist 
as an example of a tool that FDA staff use when reviewing a 510(k) 
submission. While it was not explicitly recommended, respondents had 
used the example and had included it with their 510(k) submission. We 
believe the checklist can be a helpful tool for both reviewers and 
510(k) submitters and have therefore updated the guidance to explicitly 
recommend inclusion of the checklist in the 510(k) submission. Because 
most submitters included the checklist on their own initiative and 
because it may simplify preparation of the 510(k), we do not believe 
adding the checklist to this ICR affects the overall burden for a 
510(k) submission. Additionally, we have updated the checklist to 
include combination products, as appropriate. The estimated number of 
responses as updated with current data in this submission, reflects the 
inclusion of combination products.
     We revised and reformatted Form FDA 3514, ``CDRH Premarket 
Review Submission Cover Sheet,'' to improve usability and to be 
inclusive of most medical device product submission types. Form FDA 
3514, a summary cover sheet form, assists respondents in categorizing 
510(k) information for submission to FDA. This form also assists 
respondents in categorizing information for other FDA medical device 
programs. The total burden for Form FDA 3514 and for the 510(k) program 
is estimated in this ICR. The burden for the other medical device 
programs listed on Form FDA 3514 are approved under the corresponding 
product submission ICRs as follows: premarket approval applications 
(OMB control number 0910-0231), investigational device exemptions (OMB 
control number 0910-0078), humanitarian device exemptions (control 
number 0910-0332), CLIA waivers (OMB control number 0910-0598), Q-
Submissions (OMB control number 0910-0756), De Novo requests (OMB 
control number 0910-0844), Emergency Use Authorizations (OMB control 
number 0910-0595), 513(g) requests (OMB control number 0910-0705); and 
Appeals (OMB control number 0910-0738).
     Certain revisions to Form FDA 3514, as previously 
described, eliminate the need for Form FDA 3654, ``Standards Data 
Report for 510(k)s.'' Additionally, the ability for Form FDA 3514 to be 
expandable for the number of standards cited will increase awareness of 
actual standards in a submission and how they were used on a single 
form (compared to including several Form FDA 3654 documents). In the 
rare occasions where the sponsor elects to not use Form FDA 3514 for 
standards, this would not have any effect on the review outcome, with 
regard to standards, as the form serves as a means to identify what 
standards are cited, how they are used, and where in the submission 
they are located.
     We have removed Form FDA 3541, ``Status Request.'' In 
practice, Form FDA 3541 is rarely used. We have adjusted the burden 
estimate to reflect this removal. Under Sec.  807.90(a)(3), all 
inquiries regarding a premarket notification submission should be in 
writing and sent to one of the addresses listed in Sec.  807.90(a).
     We have added burden estimates for the eSTAR and eSTAR 
setup (one-time burden). Under section 745A(b) of FD&C Act, amended by 
section 207 of FDARA (Pub. L. 115-52), and consistent with the MDUFA IV 
Commitment Letter, FDA has developed the eSTAR (eSTAR, Form FDA 4062) 
for 510(k) submissions to facilitate the preparation of submissions in 
electronic format. We expect to receive approximately 100 510(k) 
submissions via eSTAR per year. We estimate that eSTAR submissions will 
take approximately 40 hours per submission. Additionally, we've 
estimated a one-time setup burden of 5 minutes for approximately 80 new 
eSTAR users annually.
    The adjustments and revisions previously mentioned have resulted in 
a 39,473-hour decrease in the total hour burden estimate since the last 
OMB approval.

    Dated: December 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-28098 Filed 12-27-19; 8:45 am]
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