[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
  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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  ..............  ..............  ..............  .......................................           8,065
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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]
BILLING CODE 4164-01-P