Notice2022-23377
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 510(k) Third-Party Review Program
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 27, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 207 (Thursday, October 27, 2022)</title>
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[Federal Register Volume 87, Number 207 (Thursday, October 27, 2022)]
[Notices]
[Pages 65088-65089]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#510103100225303737113735307f3939227f363e27"><span class="__cf_email__" data-cfemail="633331223017020505230507024d0b0b104d040c15">[email protected]</span></a>.
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) (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-third-party-review-program">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-third-party-review-program</a>) 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\
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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.
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
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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
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