[Federal Register Volume 85, Number 74 (Thursday, April 16, 2020)]
[Notices]
[Pages 21244-21246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08011]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0804]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Premarket 
Notification Procedures

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 May 18, 2020.

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 0910-0120. Also include the FDA docket 
number found in brackets in the heading of this document.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Premarket Notification Procedures--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 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 (21 U.S.C. 379k-1(b), 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

[[Page 21245]]

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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    In the Federal Register of December 30, 2019 (84 FR 71958) we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    Upon further evaluation, however, in addition to the revisions 
discussed in our 60-day notice, we are also revising the information 
collection to include the draft guidance document entitled 
``Recognition and Withdrawal of Voluntary Consensus Standards; Guidance 
for Industry and Food and Drug Administration Staff.'' The guidance is 
being issued consistent with our Good Guidance Practice Regulations in 
21 CFR 10.115, which provides for comment at any time.
    Incorporating burden that may be associated with recommendations 
discussed in the draft guidance optimizes our operational efficiency 
with regard to requests to recognize voluntary consensus standards. The 
draft guidance document is available at https://www.fda.gov/media/115964/download and discusses procedures the Center for Devices and 
Radiological Health (CDRH) will follow when a request for recognition 
of a voluntary consensus standard is received. The draft guidance 
outlines justifications for why a standard may be recognized wholly, 
partly, or not at all, as well as reasons and rationales for 
withdrawing a standard. The draft guidance also discusses that any 
interested party may request recognition of a standard and provides 
respondents with suggested information to include in a request for 
recognition of a standard.
    In the Federal Register of September 14, 2018 (83 FR 46740), we 
published a notice announcing the availability of the draft guidance, 
including a 60-day notice under the PRA, and invited comment on 
proposed collection of information. One comment was received stating, 
information ``required'' for a recommendation for recognition of a 
standard, a description of how the requirements in the final guidance 
have been satisfied should also be included along with information 
about the standard and that a copy of the standard needs to be 
available to the public at no charge. First, we note that the commenter 
is incorrect; the draft guidance document states that the information 
in section IV.B. should be provided when requesting recognition, but it 
is not required. We believe that requiring a request to include (in 
addition to the list of recommended items) information regarding how 
each attribute or element of the voluntary consensus standards 
development process was met would be unduly burdensome. We remain 
active in and aware of many national and international voluntary 
consensus standards bodies and, therefore, are knowledgeable of how 
these groups address the attributes outlined in OMB Circular A-119, 
``Federal Participation in the Development and Use of Voluntary 
Consensus Standards and in Conformity Assessment Activities.'' If we 
have questions regarding how a specific standard was developed with 
respect to the voluntary consensus standards development process, we 
may followup with respondents for additional information on a case-by-
case basis (we believe these nonstandardized followup questions 
designed to clarify responses would be exempt from OMB review and 
approval under 5 CFR 1320.3(h)(9)).
    As indicated in FDA's guidance entitled ``Appropriate Use of 
Voluntary Consensus Standards in Premarket Submission for Medical 
Devices'': ``The use of consensus standards is not mandatory for 
medical device premarket submissions unless the consensus standard has 
been incorporated by reference into a regulation. A manufacturer may 
choose to rely on applicable consensus standards or address issues 
relevant to approval or clearance in another manner.'' Note that the 
recognition process is separate from creation of regulations that 
incorporate standards by reference. Consistent with OMB Circular A-119, 
FDA considers ``reasonable availability'' of a standard when 
determining whether to incorporate a standard by reference into 
regulation.
    We intend to finalize the guidance and we are seeking OMB approval 
of the information collection provisions discussed. We estimate the 
burden of this collection of information as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                             Number of
 Activity 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)-- FDA 4062............             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          ....................               9               1               9  1.............................               9
 voluntary consensus standard.
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    Total.........................  ....................  ..............  ..............  ..............  ..............................         319,169
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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.


[[Page 21246]]

    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 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, Section 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, and consistent with the MDUFA IV Commitment 
Letter,\2\ 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.
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    \2\ https://www.fda.gov/media/102699/download.
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     We have also added Agency guidance to assist respondents 
who request recognition of a voluntary consensus standard. The guidance 
recommends that respondents provide basic contact information to FDA 
along with details about the specific standard recognition request. 
Based on previous requests for recognition of standards, we estimate we 
will receive nine requests annually and assume that each request will 
take less than 1 hour to prepare.
    The adjustments and revisions result in a 39,464-hour decrease in 
the total hour burden estimate since the last OMB approval.

    Dated: April 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-08011 Filed 4-15-20; 8:45 am]
 BILLING CODE 4164-01-P