[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Program; Draft Guidance for Industry and Food and Drug Administration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the availability of the draft guidance entitled ``Fostering Medical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 FDA is issuing this draft guidance to describe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draft guidance is not final nor is it in effect at this time.
DATES: Submit either electronic or written comments on the draft
guidance by July 5, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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proposed collection of information in the draft guidance by July 5,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
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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'
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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:
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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]
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