[Federal Register Volume 87, Number 88 (Friday, May 6, 2022)]
[Notices]
[Pages 27165-27168]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-09734]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0109]


Fostering Medical Device Improvement: Food and Drug 
Administration Activities and Engagement With the Voluntary Improvement 
Program; Draft Guidance for Industry and Food and Drug Administration 
Staff; Availability; Agency Information Collection Activities; Proposed 
Collection; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance entitled ``Fostering Medical 
Device Improvement: FDA Activities and Engagement with the Voluntary 
Improvement Program.'' FDA is issuing this draft guidance to describe 
its policy regarding FDA's participation in the Voluntary Improvement 
Program (VIP). The VIP is a voluntary program facilitated through the 
Medical Device Innovation Consortium (MDIC) 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. The VIP builds on the framework piloted 
through FDA's 2018 Case for Quality Voluntary Medical Device 
Manufacturing and Product Quality Pilot Program (CfQ Pilot Program) and 
incorporates some of the successes and learnings from the pilot. This 
draft guidance is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by July 5, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance. Submit electronic or written comments on the 
proposed collection of information in the draft guidance by July 5, 
2022.

[[Page 27166]]


ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2022-D-0109 for ``Fostering Medical Device Improvement: FDA 
Activities and Engagement with the Voluntary Improvement Program.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    An electronic copy of the guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document entitled 
``Fostering Medical Device Improvement: FDA Activities and Engagement 
with the Voluntary Improvement Program'' to the Office of Policy, 
Guidance and Policy Development, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: With regard to the draft guidance: 
Francisco Vicenty, Center for Devices and Radiological Health, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1534, 
Silver Spring, MD 20993-0002, 301-796-5577.
    With regard to the proposed collection of information: Amber 
Sanford, Office of Operations, Food and Drug Administration, Three 
White Flint North, 10A-12M, 11601, Landsdown St., North Bethesda, MD 
20852, 301-796-8867, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    As part of Center for Devices and Radiological Health's (CDRH) 
2016-2017 strategic priority to ``Promote a Culture of Quality and 
Organizational Excellence,'' CDRH envisions a future where the medical 
device ecosystem is inherently focused on device features and 
manufacturing practices that have the greatest impact on product 
quality and patient safety. Among its other regulatory activities, FDA 
evaluates manufacturers' compliance with regulations governing the 
design and production of devices. Compliance with 21 CFR part 820, 
``Quality System Regulation,'' is a baseline requirement for medical 
device manufacturing firms.
    In an effort to elevate and enhance manufacturing practices and 
behaviors through which quality and safety of medical devices can be 
improved, FDA has collaborated with various stakeholders, brought 
together through the MDIC public-private partnership, to develop the 
CfQ Pilot Program. FDA announced the voluntary CfQ Pilot Program in the 
Federal Register on December 28, 2017 (82 FR 61575).
    As in the CfQ Pilot Program, the VIP oversees third-party 
appraisers who evaluate voluntary industry participants, and the VIP 
assesses the capability and performance of key business processes using 
a series of integrated best practices. Those practices are detailed in 
the Information Systems Audit and Control Association Capability 
Maturity Model Integration (CMMI) system. CMMI provides a roadmap that 
guides improvement towards disciplined and consistent processes for 
achieving key business objectives, including quality and performance. 
VIP uses a version of the CMMI appraisal appropriate for the medical 
device industry. This appraisal tool is referred to as the Medical 
Device Discovery Appraisal Program (MDDAP) model. The baseline 
appraisal using the MDDAP model covers 11 practices areas, including 
Estimating, Planning, and Configuration Management. As part of the VIP, 
and as in the CfQ Pilot Program, the VIP provides firms and FDA with 
information about the firm's capability and performance for activities 
covered in the third-party appraisal.

[[Page 27167]]

    Details and results from the 2018 CfQ Pilot Program are outlined in 
MDIC's Case for Quality Pilot Report, available at https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/case-quality-pilot-activities.
    This voluntary program is currently only available to eligible 
manufacturers of medical devices regulated by CDRH and 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). The voluntary CfQ Pilot Program was implemented for 
devices regulated by CDRH, and products regulated by the Center for 
Biologics Evaluation and Research (CBER) were not part of the CfQ Pilot 
Program. CBER is interested in hearing from manufacturers of device 
products regulated by CBER under sections 510(k), 513, 515, and 520 (21 
U.S.C. 360(k), 360c, 360e, and 360j) about their interest in 
participating in such a program. CBER requests comments from 
stakeholders regarding the possible application of this program to 
CBER-regulated devices.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Fostering 
Medical Device Improvement: FDA Activities and Engagement with the 
Voluntary Improvement Program.'' It does not establish any rights for 
any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the internet. A search 
capability for all CDRH guidance documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents and 
https://www.regulations.gov. Persons unable to download an electronic 
copy of ``Fostering Medical Device Improvement: FDA Activities and 
Engagement with the Voluntary Improvement Program'' may send an email 
request to [email protected] to receive an electronic copy of 
the document. Please use the document number 20039 and complete title 
to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Medical Devices; Voluntary Improvement Program

OMB Control Number 0910-NEW

    The VIP is a voluntary program facilitated through the MDIC 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. 
FDA is issuing the draft guidance entitled ``Fostering Medical Device 
Improvement: FDA Activities and Engagement with the Voluntary 
Improvement Program'' to describe its policy regarding FDA's 
participation in the VIP. As part of the VIP process, FDA receives 
information about participating device manufacturers' capability and 
performance for activities covered in third-party appraisals.
    FDA estimates the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Reporting Burden \1\ \2\
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                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
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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
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................           8,065
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Numbers in table have been rounded.

    Based on device registration and listing data and informal feedback 
from stakeholders, we anticipate approximately 400 sites may 
participate in the VIP annually.
    The estimated Average Burdens per Response are largely based on our 
experience with the voluntary CfQ Pilot Program and were determined in 
consultation with our subject matter experts who are familiar with this 
program.

Site Manufacturer Application

    Third-party appraisers forward participating site manufacturers'

[[Page 27168]]

applications to FDA. FDA confirms whether certain information in the 
application is consistent with FDA's existing records. This helps the 
third-party appraiser to determine the manufacturers' eligibility for 
participation in the VIP. We expect each application will take 
approximately 5 minutes to submit.

Aggregate Data Reporting

    The third-party appraiser provides FDA with aggregated data across 
all participating manufacturer sites quarterly. The aggregate data is 
used to identify broad industry trends and patterns that FDA may 
consider in the benefit-risk considerations FDA routinely uses to 
inform planning, improve FDA resource allocations, improve review 
efficiency, and inform risk-based inspection planning. We expect that 
it will take approximately 8 hours to prepare and submit the aggregate 
data.

Summary of Site Appraisal

    The third-party appraiser provides FDA with a summary of the 
appraisal result for each participating site. FDA intends to consider 
this information in the benefit-risk considerations FDA routinely uses 
to inform planning, improve FDA resource allocations, improve review 
efficiency, and inform risk-based inspection planning for firms that 
demonstrate capability and transparency around their manufacturing and 
product performance. We expect it will take approximately 20 hours to 
complete each summary.

The VIP and Certain Regulatory Submissions

    FDA expects to gain insights into a participant's manufacturing 
processes and control capabilities intended to satisfy recommendations 
for certain PMA or HDE submissions (e.g., PMA/HDE 30-Day Change 
Notices, PMA/HDE Manufacturing Site Change Supplements, PMA/HDE 
Manufacturing Modules). Thus, participants in the VIP may be able to 
avail themselves of efficiencies that would prevent duplicate 
information and/or allow for least burdensome submissions to FDA. FDA 
plans to improve stakeholder opportunities to use modified templates 
for such submissions.
    The draft guidance also refers to previously approved collections 
of information. These collections of information are subject to review 
by the OMB under the PRA. The collections of information in the 
following FDA regulations have been approved by OMB as listed in the 
following table:

------------------------------------------------------------------------
          21 CFR part                   Topic           OMB control No.
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814, subparts A through E.....  Premarket approval...          0910-0231
814, subpart H................  Humanitarian Device            0910-0332
                                 Exemption.
820...........................  Current Good                   0910-0073
                                 Manufacturing
                                 Practice (CGMP);
                                 Quality System (QS)
                                 Regulation.
7.............................  Recalls..............          0910-0432
803...........................  Medical Device                 0910-0437
                                 Reporting.
807, subparts A through D.....  Establishment                  0910-0625
                                 Registration and
                                 Listing.
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    Dated: April 29, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09734 Filed 5-5-22; 8:45 am]
BILLING CODE 4164-01-P