[Federal Register Volume 88, Number 144 (Friday, July 28, 2023)]
[Notices]
[Pages 48854-48855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16079]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2757]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices--
Voluntary Improvement Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, 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 August 28, 2023.
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 title of this
information collection is ``Voluntary Improvement Program.'' Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[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.
Voluntary Improvement Program
OMB Control Number 0910-NEW
This information collection supports FDA's 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 https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/voluntary-medical-device-manufacturing-and-product-quality-pilot-program, 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, 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 (including under
sections 510(k), 513, 515, and 520 (21 U.S.C. 360(k), 360c, 360e, and
360j)) may participate in the VIP. The guidance 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.
Information included in VIP applications is verified by FDA. This
helps the third-party appraiser to determine the manufacturers'
eligibility for participation in the VIP. We use aggregate data to
identify broad industry trends and patterns to help inform risk-based
inspection planning and improve review efficiencies. We also consider
aggregate data to better allocate limited Agency resources. Also
included among the goals of the program is to improve the safety,
quality, and access of medical devices for patients by driving quality
and continuous improvement within the device industry. The program is
intended to result in increased production and access to higher quality
medical devices for patients, decreases in safety issues, and lower
production costs, which will increase value to industry, patients,
providers, payors, and FDA.
We published a 60-day notice soliciting public comment on the
proposed collection of information in the Federal Register of May 6,
2022 (87 FR 27165) and received several comments. Most comments
included feedback on individual collection elements and the operational
logistics of the program. We have considered these comments. Although
we intend to revise the guidance to clarify what participants must
demonstrate to benefit from the opportunities offered by VIP and add
further details regarding the role of FDA in VIP in section V.B of the
guidance, we are making no adjustments to our burden estimates. In
addition, two comments requested FDA clarify the benefits and utility
of VIP for patients and consumers. FDA intends to address these
comments in the guidance document, which guides improvement to enhance
the quality of devices.
Respondents: Respondents to the information collection are
manufacturing sites who voluntary elect to participate in the VIP.
Based on our device registration and listing data and informal feedback
from stakeholders, we anticipate approximately 400 sites may
participate annually.
We estimate the burden of the information collection as follows:
[[Page 48855]]
Table 1--Estimated Annual Reporting Burden \1\
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Recommended information collection activity:
Fostering medical device improvement: FDA Number of Number of Total annual
activities and engagement with the voluntary respondents responses per responses Average burden per response Total hours
Improvement Program respondent
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Site manufacturer application.................. 1 400 400 0.08 (5 minutes)....................... 33
Aggregate data reporting....................... 1 4 4 8...................................... 32
Summary of site appraisal...................... 1 400 400 20..................................... 8,000
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Total...................................... .............. .............. .............. ....................................... 8,065
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\1\ There are no capital or operating and maintenance costs associated with the information collection.
Site Manufacturer Application
In section IV.A of the guidance, we explain that manufacturers
wishing to apply for an appraisal may do so at the third-party
appraiser's application portal. As part of the VIP process (see section
IV.D, Process Flow, of the guidance), the site manufacturers'
application information is provided to FDA by the third-party
appraiser. We assume it will take the third-party appraiser
approximately 5 minutes to notify FDA of the availability of each
application. Such notification is provided via email and FDA may then
access the information via the third-party appraiser's online portal.
Aggregate Data Reporting
As discussed in sections III and IV of the guidance, the third-
party appraiser provides FDA with aggregated data across all
participating manufacturer sites quarterly. We assume that it will take
approximately 8 hours to prepare and submit the aggregate data.
Summary of Site Appraisal
In section IV.D of the guidance, we communicate that the third-
party appraiser will provide FDA a summary of the appraisal result for
each participating site. We assume an average of 20 hours is necessary
to prepare and submit the summary.
This is a new information collection. Specifically, we are
accounting for third-party appraiser burden to provide the site
manufacturer's information to FDA under the VIP process. We believe
associated recordkeeping by participating manufactures to be usual and
customary business practice and have therefore not included estimates
for VIP application activities by manufacturers. The estimated average
burden per response is largely based on our experience with the program
pilot and informal communications with participants.
Dated: July 25, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16079 Filed 7-27-23; 8:45 am]
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