Document ID: FDA-2016-D-2565-0022
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; 510(k) Third-Party Review Program
Posted Date: 2022-06-24T04:00Z

[Federal Register Volume 87, Number 121 (Friday, June 24, 2022)]
[Notices]
[Pages 37863-37865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-13521]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2565]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; 510(k) Third-Party Review Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) 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 the 510(k) Third-Party Review Program.

DATES: Submit either electronic or written comments on the collection 
of information by August 23, 2022.

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 August 23, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of August 23, 2022. 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-2016-D-2565 for ``Agency Information Collection Activities; 
Submission for Office of Management and Budget Review; Comment Request; 
510(k) Third-Party Review Program.'' 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.

[[Page 37864]]

     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: Rachel Showalter, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, 
[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.

510(k) Third-Party Review Program

OMB Control Number 0910-0375--Extension

    Section 523 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 360m), directs FDA to accredit persons in the private sector 
to review certain premarket notifications (510(k)s; see 21 U.S.C. 
360(k)). Participation in the 510(k) third party (3P510k) review 
program by accredited persons is entirely voluntary. A third party 
wishing to participate will submit a request for accreditation to FDA. 
Accredited third-party reviewers have the ability to review a 
manufacturer's 510(k) submission for selected devices. After reviewing 
a submission, the reviewer will forward a copy of the 510(k) 
submission, along with the reviewer's documented review and 
recommendation, to FDA. Third-party reviewers should maintain records 
of their 510(k) reviews and a copy of the 510(k) for a reasonable 
period of time, usually 3 years.
    Respondents to this information collection are businesses or 
government, and can be for-profit or not-for-profit organizations.
    The guidance ``510(k) Third-Party Review Program, Guidance for 
Industry, Food and Drug Administration Staff and Third Party Review 
Organizations'' (March 2020) (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-third-party-review-program) is intended to provide a comprehensive look into FDA's current 
thinking regarding the 3P510k review program. This guidance document 
also reflects section 523 of the FD&C Act, which directs FDA to issue 
guidance on the factors that will be used in determining whether a 
class I or class II device type, or subset of such device types, is 
eligible for review by an accredited person. The 3P510k review program 
is intended to allow review of devices by third-party 510k review 
organizations (3PROs) to provide manufacturers of these devices an 
alternative review process that allows FDA to best utilize our 
resources on higher risk devices.
    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; guidance document section          Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses                                                     \2\
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Requests for accreditation (initial); Section               1               1               1  24.......................................              24
 VI.
Requests for accreditation (re-recognition);                3               1               3  24.......................................              72
 Section VI
510(k) reviews conducted by accredited third                9              14             126  40.......................................           5,040
 parties; Section VI
Complaints; Section VII......................               1               1               1  0.25 (15 minutes)........................               1
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    Total....................................  ..............  ..............  ..............  .........................................           5,137
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Totals have been rounded.

[[Page 37865]]

                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of                        Average
   Activity; guidance document       Number of      records per    Total annual     burden per      Total hours
             section               recordkeepers   recordkeeper       records      recordkeeping
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510(k) reviews; Section VII.....               9              14             126              10           1,260
Records regarding qualifications               9               1               9               1               9
 to receive FDA recognition as a
 3PRO; Section VII..............
Recordkeeping system regarding                 9               1               9               2              18
 complaints; Section VII........
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    Total.......................  ..............  ..............  ..............  ..............           1,287
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

Estimated Annual Recordkeeping Burden
    510(k) reviews: The 3PROs should retain copies of all 510(k) 
reviews and associated correspondence. Based on FDA's recent experience 
with this program, we estimate the number of 510(k)s submitted for 
3P510k review to be 126 annually; approximately 14 annual reviews for 
each of the 9 3PROs. We estimate the average burden per recordkeeping 
to be 10 hours.
    Records regarding qualifications to receive FDA recognition as a 
3PRO: Under section 704(f) of the FD&C Act (21 U.S.C. 374(f)), a 3PRO 
must maintain records that support their initial and continuing 
qualifications to receive FDA recognition, including documentation of 
the training and qualifications of the 3PRO and its personnel; the 
procedures used by the 3P510k review organization for handling 
confidential information; the compensation arrangements made by the 
3PRO; and the procedures used by the 3PRO to identify and avoid 
conflicts of interest. Additionally, the guidance states that 3PROs 
should retain information on the identity and qualifications of all 
personnel who contributed to the technical review of each 510(k) 
submission and other relevant records. Because most of the burden of 
compiling the records is expressed in the reporting burden for requests 
for accreditation, we estimate the maintenance of such records to be 1 
hour per recordkeeping annually.
    Recordkeeping system regarding complaints: Section 523(b)(3)(F)(iv) 
of the FD&C Act requires 3PROs to agree in writing that they will 
promptly respond and attempt to resolve complaints regarding their 
activities. The guidance recommends that 3PROs establish a 
recordkeeping system for tracking the submission of those complaints 
and how those complaints were resolved, or attempted to be resolved. 
Based on our experience with the program and the recommendations in the 
guidance, we estimate the average burden per recordkeeping to be 2 
hours annually.
    Based on our experience with the program since our last request for 
OMB approval, we have adjusted our burden estimate, which has resulted 
in a decrease to the currently approved burden.

    Dated: June 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13521 Filed 6-23-22; 8:45 am]
BILLING CODE 4164-01-P