Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Improvement Program

Issuing agencies

Abstract

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.

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<title>Federal Register, Volume 91 Issue 189 (Thursday, October 1, 2026)</title>
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[Federal Register Volume 91, Number 189 (Thursday, October 1, 2026)]
[Notices]
[Pages 62528-62530]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20085]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-N-6876]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Voluntary Improvement 
Program

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 November 2, 2026.

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 0910-0922. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Kelly Covington, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 240-402-5661, 
<a href="/cdn-cgi/l/email-protection#95c5c7d4c6e1f4f3f3d5f3f1f4bbfdfde6bbf2fae3"><span class="__cf_email__" data-cfemail="227270637156434444624446430c4a4a510c454d54">[email&#160;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.

Medical Devices; Voluntary Improvement Program

OMB Control Number 0910-0922--Extension

    This information collection supports Food and Drug Administration 
(FDA, us or we) implementation of its Voluntary Improvement Program 
(VIP). Included among the strategic priorities of our Center for 
Devices and Radiological Health (CDRH) is promoting a culture of 
quality and organizational excellence. As communicated on our website 
at <a href="https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/voluntary-medical-device-manufacturing-and-product-quality-pilot-program">https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/voluntary-medical-device-manufacturing-and-product-quality-pilot-program</a>, we conducted a pilot project pertaining to voluntary 
medical device manufacturing and product quality and have incorporated 
some of the successes and learnings into the VIP. The VIP oversees 
third-party appraisers who evaluate industry participants. The VIP is 
facilitated by the Medical Device Innovation Consortium (MDIC), a 
public-private partnership that evaluates the capability and 
performance of a medical device manufacturer's practices using third-
party appraisals and is intended to guide improvement to enhance the 
quality of devices. As part of the VIP process, FDA receives 
information about participating device manufacturers' capability and 
performance for activities covered in third-party appraisals.
    The guidance document entitled, ``Fostering Medical Device 
Improvement: FDA Activities and Engagement with the Voluntary 
Improvement Program,'' communicates our policy regarding participation 
in the VIP. Only eligible manufacturers of medical devices regulated by 
CDRH whose marketing applications are reviewed under the applicable 
provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(including sections 510(k), 513, 515, and 520) may participate in the 
VIP. The guidance

[[Page 62529]]

document was developed and issued consistent with our Good Guidance 
Practice regulations in 21 CFR 10.115, which provide for public comment 
at any time. The guidance document includes instruction to respondents 
regarding eligibility, FDA engagement with participants, submission 
criteria, and withdrawal or removal from the program.
    In the Federal Register of July 17, 2026 (91 FR 44852), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received.
    FDA received one comment from an individual. The commenter 
supported extending the VIP information collection and organized his 
remarks around the four questions in the 60-day notice, as summarized 
here:
    The commenter affirmed the value of VIP appraisal data as a 
proactive quality signal and suggested FDA publish de-identified, 
aggregated benchmark data from appraisal results, particularly to 
assist smaller manufacturers of high-risk devices during the QMSR 
transition.
    The commenter asserted that the 20-hour estimate for the summary of 
site appraisal is significantly low for first-time participants and 
recommended either splitting the estimate into initial and repeat 
appraisal figures or surveying current VIP participants to validate it. 
The commenter also noted that if the estimate covers only the 
incremental reporting burden, the supporting statement should make that 
scoping assumption explicit. The commenter recommended (1) capturing 
repeat-nonconformance rates for issues previously closed through CAPA 
as a complement to maturity scores, and (2) adopting a standardized 
summary template to improve comparability across sites and appraisal 
cycles. The commenter suggested (1) offering a structured electronic 
submission form, (2) pre-populating identifying fields from existing 
establishment registration and device listing data, and (3) allowing 
repeat participants to submit delta reports covering only changes since 
the last appraisal.
    FDA has taken note of the commenter's suggestion to publish de-
identified, aggregated benchmark data derived from appraisal results. 
This information is currently available to VIP participants. As VIP is 
a voluntary improvement program, not a compliance program, 
participation data is submitted to FDA by the third-party appraiser 
with no commitment that it will be shared publicly. Accordingly, FDA 
does not plan to make this information available to the public at this 
time.
    FDA acknowledges the commenter's concern regarding the accuracy of 
the 20-hour burden estimate for the summary of site appraisal, 
particularly as it applies to first-time participants. However, the 20-
hour estimate refers to the time spent by the third-party appraiser, 
not the device manufacturer, to prepare and submit a summary of the 
site appraisal to FDA. Because this information collection captures the 
burden imposed on the third-party appraiser, the commenter's experience 
preparing manufacturing sites for appraisal does not directly relate to 
this estimate. FDA has not received any information or feedback 
regarding the accuracy of this estimate of the burden on the third-
party appraiser and no changes to this burden estimate are appropriate, 
based on the comment.
    FDA also acknowledges the commenter's suggestion to provide 
estimates to separate initial vs. subsequent appraisals but has not 
received any information or feedback relating to accuracy of the 20-
hour estimate for the third-party appraiser. (1) FDA has considered the 
commenter's recommendation to capture nonconformance rates for issues 
previously closed through CAPA. FDA acknowledges the comment that 
recurrence data may provide value not found in maturity scores alone. 
However, as VIP is a voluntary improvement program and not a compliance 
program, capturing either recurrence data or reasons for CAPA failure 
is outside the current scope of the information the program is designed 
to collect. (2) FDA agrees that comparability across sites and 
appraisal cycles can be useful under the proper circumstances. However, 
the VIP is structured so that participants work with the appraisers to 
create an individualized, mutually-agreed upon appraisal process. As 
such, each VIP participant firm may focus on a different set of quality 
measures as part of its appraisal process. As a result of these 
differences, there would be limited value in comparability across 
participants and FDA does not plan to make changes to the program to 
increase comparability.
    FDA appreciates the commenter's suggestions for reducing respondent 
burden. As this is a third-party appraisal program, FDA relies on the 
third-party-appraiser's expertise in implementing a successful 
appraisal program including determining the method of collecting data 
and choosing the format of submissions. With respect to pre-populating 
fields from establishment registration and device listing data, FDA 
notes that, because these are independent third-party programs, 
appraisers do not necessarily have direct access to FDA databases and 
submissions. Furthermore, VIP is not limited to one third party 
appraiser and may employ different appraisers using different methods. 
Accordingly, FDA does not believe a common application form or a 
standardized delta-reporting format based on prior submissions would be 
appropriate.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 1--Estimated Annual Reporting Burden
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    Recommended information
collection activity: Fostering
  Medical Device Improvement:      Number of        Number of      Total annual   Average burden
FDA Activities and  Engagement    respondents    responses  per      responses     per response     Total hours
With the Voluntary Improvement                     respondent
            Program
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Site manufacturer application.               1               300             300            0.08              24
Aggregate data reporting......               1                 4               4               8              32
Summary of site appraisal.....               1               300             300              20           6,000
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    Total.....................  ..............  ................  ..............  ..............           6,056
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    Our estimated burden for the information collection reflects an 
overall decrease of 2,009 hours and a corresponding decrease of 200 
responses. We attribute this adjustment based on our device 
registration and listing data and informal feedback from stakeholders.


[[Page 62530]]


Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-20085 Filed 9-30-26; 8:45 am]
BILLING CODE 4164-01-P


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