Document ID: FDA-2016-D-2565-0027
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 510(k) Third-Party Review Program
Posted Date: 2022-10-27T04:00Z

[Federal Register Volume 87, Number 207 (Thursday, October 27, 2022)]
[Notices]
[Pages 65088-65089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23377]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA 2016-D-2565]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 we) 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 November 28, 2022.

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 0910-0375. Also include the FDA docket 
number found in brackets in the heading of this document.

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

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.
    In the Federal Register of June 24, 2022 (87 FR 37863), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although four comments were received, they 
were not responsive to the four collection of information topics 
solicited.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
     Activity; guidance document section          Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses                                                     \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
                                              ----------------------------------------------------------------------------------------------------------
    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.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                    Number of                     Average burden
  Activity; guidance document      Number of       records per    Total annual         per          Total hours
            section              recordkeepers    recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
510(k) reviews; Section VII...                9              14             126               10           1,260
Records regarding                             9               1               9                1               9
 qualifications to receive FDA
 recognition as a 3PRO;
 Section VII..................
Recordkeeping system regarding                9               1               9                2              18
 complaints; Section VII......
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[[Page 65089]]

 
    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: October 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23377 Filed 10-26-22; 8:45 am]
BILLING CODE 4164-01-P