Voluntary Medical Device Manufacturing and Product Quality Program; Public Workshop; Request for Comments, 34531-34534 [2017-15542]
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34531
Federal Register / Vol. 82, No. 141 / Tuesday, July 25, 2017 / Notices
with administrators, staff, and/or clients
in each of the approximately six sites.
OPRE will field client and/or staff
surveys in order to hear from a breadth
of perspectives. In addition to
interviews, focus groups, and surveys,
OPRE anticipates observing program
activities and reviewing documents and
administrative data. This information
will be critical to diagnosing where and
why programs are facing challenges and
which behavioral interventions may
have an impact.
During the testing phase OPRE
anticipates conducting mixed-methods
evaluations consisting of
implementation, impact, and cost
research for the approximately two tests
in each of the approximately six total
sites that will be engaged across the two
program areas included under this
clearance, TANF and Child Welfare (for
a total of 12 tests). To better understand
how the intervention is being
implemented and its effects, OPRE
anticipates conducting interviews and
focus groups with program
administrators, staff, and/or clients in
each site. Because not all outcomes of
interest (for example, improved
understanding of and/or satisfaction
with the foster parent recruitment
process) are reflected in administrative
records, OPRE anticipates conducting
client surveys and staff surveys.
Interest in participating in BIAS–NG
is expected to be high, and it is not
expected that systematic recruitment of
sites will be necessary. Within each site,
we do not intend to do any active
recruitment as all those who are eligible
will be enrolled in the study and
randomization will be conducted using
a list of those who meet the eligibility
criteria. Findings from these tests will
be publicized through multiple
dissemination channels, which may
include but are not limited to reports on
individual tests, a final synthesis report,
presentations at conferences and
meetings, scholarly journal articles,
webinars, social media, press outreach,
newsletters, etc.
Respondents: (1) Program
Administrators, (2) Program Staff and
(3) Program Clients.
TOTAL BURDEN HOURS
Total number
of respondents
Instrument
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Diagnosis and Design Phase
Administrator interviews/focus groups .....................................................
Staff interviews/focus groups ...................................................................
Client interviews/focus groups .................................................................
Client survey ............................................................................................
Staff Survey .............................................................................................
24
48
48
600
120
1
1
1
1
1
1
1
1
.25
.25
24
48
48
150
30
48
96
96
6,000
120
1
1
1
1
1
1
1
1
.25
.25
48
96
96
1,500
30
Evaluation Phase
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Administrator interviews/focus groups .....................................................
Staff interviews/focus groups ...................................................................
Client interviews/focus groups .................................................................
Client Survey ...........................................................................................
Staff survey ..............................................................................................
Estimated Total Burden Hours: 2,070
hours.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 330
C Street SW., Washington, DC 20201,
Attn: OPRE Reports Clearance Officer.
All requests should be identified by the
title of the information collection. Email
address: OPREinfocollection@
acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
VerDate Sep<11>2014
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Jkt 241001
Desk Officer for the Administration for
Children and Families.
Mary Jones,
ACF/OPRE, Certifying Officer.
[FR Doc. 2017–15523 Filed 7–24–17; 8:45 am]
BILLING CODE 4184–07–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–4180]
Voluntary Medical Device
Manufacturing and Product Quality
Program; Public Workshop; Request
for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
SUMMARY:
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workshop entitled ‘‘Voluntary Medical
Device Manufacturing and Product
Quality Program.’’ The purpose of the
public workshop is to announce the
proposed framework and preliminary
outline of a voluntary pilot program that
recognizes an independent assessment
of manufacturing and product quality.
The workshop is intended to discuss the
framework of the voluntary pilot
program, information on the
independent assessment, details of
participation, rules of engagement,
monitoring and performance
expectations, as well as potential
modifications to FDA’s oversight actions
in response to demonstrated
manufacturing quality performance.
FDA is soliciting public feedback to aid
in the development of science-based
approaches to regulatory decision
making for assessing manufacturing
quality, extent of manufacturing related
submissions, and how to better allocate
resources to lower the regulatory burden
on manufacturers and FDA.
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Federal Register / Vol. 82, No. 141 / Tuesday, July 25, 2017 / Notices
The public workshop will be
held on October 10, 2017, from 8 a.m.
to 4:30 p.m. Submit either electronic or
written comments on this public
workshop by October 18, 2017. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
Rm. 1503 (the Great Room), Silver
Spring, MD 20993–0002. Entrance for
the public workshop participants (nonFDA employees) is through Building 1
where routine security check
procedures will be performed. For
parking and security information, please
refer to https://www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before October 18, 2017. The
https://www.regulations.gov electronic
filing system will accept comments
until midnight Eastern Time at the end
of October 18, 2017. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
DATES:
mstockstill on DSK30JT082PROD with NOTICES
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’’).
VerDate Sep<11>2014
19:30 Jul 24, 2017
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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–
2017–N–4180 for ‘‘Voluntary Medical
Device Manufacturing and Product
Quality Program.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), 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.
• 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
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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.
FOR FURTHER INFORMATION CONTACT:
Francisco Vicenty, Food and Drug
Administration, Center for Devices and
Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3426,
Silver Spring, MD 20993, 301–796–
5577, email: Francisco.Vicenty@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The FDA’s Center for Devices and
Radiological Health (CDRH or the
Center) launched the Case for Quality
initiative (Ref. 1) in 2011 to identify
those practices that can promote a
culture of quality and the
implementation of a quality
management approach that fosters
continuous product quality. Since then,
CDRH has engaged with a wide variety
of stakeholders from the medical device
ecosystem, including industry, patients,
governmental and academic partners,
and payer/provider counterparts to
identify key factors affecting medical
device quality and develop innovative
ways to afford patient access to higher
quality medical devices. As part of
CDRH’s 2016–2017 strategic priority to
‘‘Promote a Culture of Quality and
Organizational Excellence’’ (Ref. 2),
CDRH envisions a future state 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. The purpose of the public
workshop is to present the proposed
framework of a voluntary pilot program
to recognize independent evaluation of
product and manufacturing quality to
strengthen product and manufacturing
quality within the medical device
ecosystem. This workshop will explore
approaches to increase manufacturing
and product quality, which may
translate into better patient safety and
outcomes, and discuss new approaches
that are intended to lower the regulatory
burden on demonstrating quality
assurance, and acknowledge alternate
methods for assuring safety and
effectiveness during product
development and manufacturing.
Historically, the FDA has evaluated
manufacturers’ compliance with
regulations governing the design and
production of devices. Compliance with
the Quality System regulation (Ref. 3) is
a baseline requirement for medical
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Federal Register / Vol. 82, No. 141 / Tuesday, July 25, 2017 / Notices
device manufacturing firms. Focusing
on elevating manufacturing quality
practices gives greater emphasis to these
practices, which should correlate to
higher quality outcomes. This will allow
FDA to adjust how we recognize and
incentivize how the safety and
effectiveness of a medical device is
assured. CDRH intends to continue
working with stakeholders to assess and
promote manufacturers’ implementation
of manufacturing quality practices in
day-to-day device design and
production.
Through collaboration with the
Medical Device Innovation Consortium
(MDIC) over the last 2 years, a maturity
model and appraisal system (i.e.,
Capability Maturity Model Integration
(CMMI) system) that can be adapted for
the medical device industry was
selected (Ref. 4) for this voluntary pilot
program. The CMMI system is a process
level improvement, training, and
appraisal program. This program is
administered by the CMMI Institute and
helps organizations discover the true
value they can deliver by building
capability in their people and processes
(Ref. 5). This model has been
successfully used in various industries,
including information technology,
healthcare, automotive, defense, and
aerospace, to consistently deliver high
quality products and reduce waste and
defects. The CMMI institute certifies
and coordinates third party appraisers
evaluating voluntary industry
participants and any data necessary to
demonstrate product performance. The
appraiser would evaluate the firm’s
quality system maturity and
manufacturing processes, and identify
any gaps or where a participating firm
is performing above a compliance
baseline. The CMMI maturity appraisal
process is not intended to serve as an
FDA inspection nor is it intended to be
a new regulatory requirement.
Conducting independent-assessments
using a maturity model is intended to be
a driver of continuous process and
product improvement and business
value to voluntary participants in the
pilot program.
Assessments under the CMMI
Institute are classified as Standard
CMMI Appraisal Method for Process
Improvement (SCAMPI) elements. As
noted, a gap assessment (SCAMPI–C)
will be a part of the voluntary pilot
program. SCAMPI–C is a critical tool for
developing an in-depth understanding
of the medical device manufacturer’s
current state of process performance.
SCAMPI–C is a short and flexible
appraisal. It is used to assess the
adequacy of planned approaches to
process implementation and to provide
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a quick analysis between the
organization’s processes and CMMI
practices. It provides a rich dataset that
reflects organizational performance and
a comparison of the medical device
manufacturer’s performance against the
CMMI model.
The next steps for Case for Quality
and key discussion topics for this public
workshop are the announcement of a
maturity model appraisal framework
and implementation plan for a
voluntary pilot program. These will
incorporate an independent assessment
of manufacturing and product quality
into the way medical devices are
regulated while maintaining
organizational excellence. Further, this
workshop is intended to discuss least
burdensome opportunities as incentives
for manufacturers that participate in the
voluntary pilot program and have
demonstrated high performance in
manufacturing quality.
II. Topics for Discussion at the Public
Workshop
Following are a list of topics that are
planned to be included for discussion at
the public workshop:
• Background on Case for Quality and
proposed use of the CMMI Assessments.
• Proposed Voluntary Program
Framework and Implementation Plan:
Æ Enrollment and participation;
Æ Assessment strategy;
Æ Audit credentials—Details on how
assessors will be evaluated and
accredited;
Æ Cost of the independent assessment
and sustaining a voluntary program;
Æ Monitoring requirements and
frequency of progress updates;
Æ Data collection requirements;
metrics that can be trended over time to
provide assurance of sustained
performance versus inspection or
assessment; and
Æ Data sharing guidelines;
information shared between industry
and third party, and industry and FDA.
• Possible modifications to decrease
FDA regulatory burdens for
manufacturers with demonstrated high
quality:
Æ Inspectional strategies;
Æ Manufacturing submissions—
Reducing burden and accelerating time
to market, and
Æ Regulatory activities—Recognizing
alternate methods for demonstrating
product quality assurance and problem
solving and resolution before escalating
to enforcement actions.
• Health outcomes to patients, value
to industry, and benefits to health care.
• Identifying new risks and
mitigation strategies.
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34533
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, please visit FDA’s Medical
Devices News & Events—Workshops &
Conferences calendar at https://
www.fda.gov/MedicalDevices/News
Events/WorkshopsConferences/
default.htm. (Select this public
workshop from the posted events list.)
Please provide complete contact
information for each attendee, including
name, title, affiliation, address, email,
and telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public workshop must
register by September 29, 2017, at 4 p.m.
Eastern Time. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. Registrants will receive
confirmation when they have been
accepted. If time and space permit,
onsite registration on the day of the
public workshop will be provided
beginning at 8 a.m. We will let
registrants know if registration closes
before the day of the public workshop.
If you need special accommodations
due to a disability, please contact Peggy
Roney at Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5231, Silver Spring,
MD 20993–0002, 301–796–5671, email:
Peggy.Roney@fda.hhs.gov, no later than
September 26, 2017.
Requests for Oral Presentations:
During online registration you may
indicate if you wish to present during a
public comment session or participate
in a specific session, and which topic(s)
you wish to address. We will do our
best to accommodate requests to make
public comments and requests to
participate in the focused sessions.
Individuals and organizations with
common interests are urged to
consolidate or coordinate their
presentations, and request time for a
joint presentation, or submit requests for
designated representatives to participate
in the focused sessions. Following the
close of registration, we will determine
the amount of time allotted to each
presenter and the approximate time
each oral presentation is to begin, and
will select and notify participants by
October 4, 2017. All requests to make
oral presentations must be received by
the close of registration on September
29, 2017. If selected for presentation,
any presentation materials must be
emailed to the Francisco Vicenty (see
FOR FURTHER INFORMATION CONTACT) no
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Federal Register / Vol. 82, No. 141 / Tuesday, July 25, 2017 / Notices
later than October 3, 2017. No
commercial or promotional material
will be permitted to be presented or
distributed at the public workshop.
Streaming webcast of the public
workshop: This public workshop will
also be webcast. The webcast link will
be available on the registration Web
page after October 3, 2017.
Organizations are requested to register
all participants, but to view using one
connection per location.
If you have never attended a Connect
Pro event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has
verified the Web site addresses in this
document, as of the date this document
publishes in the Federal Register, but
Web sites are subject to change over
time.
Transcripts: Please be advised that as
soon as a transcript of the public
workshop is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Dockets Management Staff (see
ADDRESSES). A link to the transcript will
also be available on the Internet at
https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm. (Select this public
workshop from the posted events list.)
IV. References
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The following references are on
display in the Dockets Management
Staff (see ADDRESSES), and are available
for viewing by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the Web site addresses, as of the date
this document publishes in the Federal
Register, but Web sites are subject to
change over time.
1. FDA’s CDRH Case for Quality Initiative
is available at: https://www.fda.gov/
MedicalDevices/DeviceRegulationand
Guidance/MedicalDeviceQualityand
Compliance/ucm378185.htm.
2. CDRH, 2016–2017 ‘‘Promote a Culture of
Quality and Organizational Excellence’’
available at: https://www.fda.gov/downloads/
AboutFDA/CentersOffices/OfficeofMedical
ProductsandTobacco/CDRH/CDRHVisionand
Mission/UCM481588.pdf.
3. The Quality System regulation available
at: https://www.ecfr.gov/cgi-bin/text-idx?
SID=54a4a38f9c25eeab900b1c8f6c
0f4212&mc
=true&node=pt21.8.820&rgn=div5.
4. MDIC available at: https://mdic.org/.
5. CMMI system available at: https://
cmmiinstitute.com/.
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19:30 Jul 24, 2017
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Dated: July 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–15542 Filed 7–24–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–D–0369]
Animal Drug User Fees and Fee
Waivers and Reductions; Revised
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance for industry (GFI) #170
entitled ‘‘Animal Drug User Fees and
Fee Waivers and Reductions.’’ This
revised guidance document describes
the types of fees that FDA is authorized
to collect under the Animal Drug User
Fee Act of 2003, as amended, and how
to request waivers and reductions of
these fees.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
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
PO 00000
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Fmt 4703
Sfmt 4703
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–
2004–D–0369 for ‘‘Animal Drug User
Fees and Fee Waivers and Reductions.’’
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.
• 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
E:\FR\FM\25JYN1.SGM
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Agencies
[Federal Register Volume 82, Number 141 (Tuesday, July 25, 2017)]
[Notices]
[Pages 34531-34534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15542]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-4180]
Voluntary Medical Device Manufacturing and Product Quality
Program; Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``Voluntary Medical
Device Manufacturing and Product Quality Program.'' The purpose of the
public workshop is to announce the proposed framework and preliminary
outline of a voluntary pilot program that recognizes an independent
assessment of manufacturing and product quality. The workshop is
intended to discuss the framework of the voluntary pilot program,
information on the independent assessment, details of participation,
rules of engagement, monitoring and performance expectations, as well
as potential modifications to FDA's oversight actions in response to
demonstrated manufacturing quality performance. FDA is soliciting
public feedback to aid in the development of science-based approaches
to regulatory decision making for assessing manufacturing quality,
extent of manufacturing related submissions, and how to better allocate
resources to lower the regulatory burden on manufacturers and FDA.
[[Page 34532]]
DATES: The public workshop will be held on October 10, 2017, from 8
a.m. to 4:30 p.m. Submit either electronic or written comments on this
public workshop by October 18, 2017. See the SUPPLEMENTARY INFORMATION
section for registration date and information.
ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31, Rm. 1503 (the Great Room), Silver
Spring, MD 20993-0002. Entrance for the public workshop participants
(non-FDA employees) is through Building 1 where routine security check
procedures will be performed. For parking and security information,
please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before October 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of October 18, 2017. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
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-2017-N-4180 for ``Voluntary Medical Device Manufacturing and
Product Quality Program.'' Received comments, those filed in a timely
manner (see ADDRESSES), 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.
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.gpo.gov/fdsys/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.
FOR FURTHER INFORMATION CONTACT: Francisco Vicenty, Food and Drug
Administration, Center for Devices and Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3426, Silver Spring, MD 20993, 301-796-
5577, email: Francisco.Vicenty@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The FDA's Center for Devices and Radiological Health (CDRH or the
Center) launched the Case for Quality initiative (Ref. 1) in 2011 to
identify those practices that can promote a culture of quality and the
implementation of a quality management approach that fosters continuous
product quality. Since then, CDRH has engaged with a wide variety of
stakeholders from the medical device ecosystem, including industry,
patients, governmental and academic partners, and payer/provider
counterparts to identify key factors affecting medical device quality
and develop innovative ways to afford patient access to higher quality
medical devices. As part of CDRH's 2016-2017 strategic priority to
``Promote a Culture of Quality and Organizational Excellence'' (Ref.
2), CDRH envisions a future state 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. The
purpose of the public workshop is to present the proposed framework of
a voluntary pilot program to recognize independent evaluation of
product and manufacturing quality to strengthen product and
manufacturing quality within the medical device ecosystem. This
workshop will explore approaches to increase manufacturing and product
quality, which may translate into better patient safety and outcomes,
and discuss new approaches that are intended to lower the regulatory
burden on demonstrating quality assurance, and acknowledge alternate
methods for assuring safety and effectiveness during product
development and manufacturing.
Historically, the FDA has evaluated manufacturers' compliance with
regulations governing the design and production of devices. Compliance
with the Quality System regulation (Ref. 3) is a baseline requirement
for medical
[[Page 34533]]
device manufacturing firms. Focusing on elevating manufacturing quality
practices gives greater emphasis to these practices, which should
correlate to higher quality outcomes. This will allow FDA to adjust how
we recognize and incentivize how the safety and effectiveness of a
medical device is assured. CDRH intends to continue working with
stakeholders to assess and promote manufacturers' implementation of
manufacturing quality practices in day-to-day device design and
production.
Through collaboration with the Medical Device Innovation Consortium
(MDIC) over the last 2 years, a maturity model and appraisal system
(i.e., Capability Maturity Model Integration (CMMI) system) that can be
adapted for the medical device industry was selected (Ref. 4) for this
voluntary pilot program. The CMMI system is a process level
improvement, training, and appraisal program. This program is
administered by the CMMI Institute and helps organizations discover the
true value they can deliver by building capability in their people and
processes (Ref. 5). This model has been successfully used in various
industries, including information technology, healthcare, automotive,
defense, and aerospace, to consistently deliver high quality products
and reduce waste and defects. The CMMI institute certifies and
coordinates third party appraisers evaluating voluntary industry
participants and any data necessary to demonstrate product performance.
The appraiser would evaluate the firm's quality system maturity and
manufacturing processes, and identify any gaps or where a participating
firm is performing above a compliance baseline. The CMMI maturity
appraisal process is not intended to serve as an FDA inspection nor is
it intended to be a new regulatory requirement. Conducting independent-
assessments using a maturity model is intended to be a driver of
continuous process and product improvement and business value to
voluntary participants in the pilot program.
Assessments under the CMMI Institute are classified as Standard
CMMI Appraisal Method for Process Improvement (SCAMPI) elements. As
noted, a gap assessment (SCAMPI-C) will be a part of the voluntary
pilot program. SCAMPI-C is a critical tool for developing an in-depth
understanding of the medical device manufacturer's current state of
process performance. SCAMPI-C is a short and flexible appraisal. It is
used to assess the adequacy of planned approaches to process
implementation and to provide a quick analysis between the
organization's processes and CMMI practices. It provides a rich dataset
that reflects organizational performance and a comparison of the
medical device manufacturer's performance against the CMMI model.
The next steps for Case for Quality and key discussion topics for
this public workshop are the announcement of a maturity model appraisal
framework and implementation plan for a voluntary pilot program. These
will incorporate an independent assessment of manufacturing and product
quality into the way medical devices are regulated while maintaining
organizational excellence. Further, this workshop is intended to
discuss least burdensome opportunities as incentives for manufacturers
that participate in the voluntary pilot program and have demonstrated
high performance in manufacturing quality.
II. Topics for Discussion at the Public Workshop
Following are a list of topics that are planned to be included for
discussion at the public workshop:
Background on Case for Quality and proposed use of the
CMMI Assessments.
Proposed Voluntary Program Framework and Implementation
Plan:
[cir] Enrollment and participation;
[cir] Assessment strategy;
[cir] Audit credentials--Details on how assessors will be evaluated
and accredited;
[cir] Cost of the independent assessment and sustaining a voluntary
program;
[cir] Monitoring requirements and frequency of progress updates;
[cir] Data collection requirements; metrics that can be trended
over time to provide assurance of sustained performance versus
inspection or assessment; and
[cir] Data sharing guidelines; information shared between industry
and third party, and industry and FDA.
Possible modifications to decrease FDA regulatory burdens
for manufacturers with demonstrated high quality:
[cir] Inspectional strategies;
[cir] Manufacturing submissions--Reducing burden and accelerating
time to market, and
[cir] Regulatory activities--Recognizing alternate methods for
demonstrating product quality assurance and problem solving and
resolution before escalating to enforcement actions.
Health outcomes to patients, value to industry, and
benefits to health care.
Identifying new risks and mitigation strategies.
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit
FDA's Medical Devices News & Events--Workshops & Conferences calendar
at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)
Please provide complete contact information for each attendee,
including name, title, affiliation, address, email, and telephone.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by September 29, 2017, at 4 p.m. Eastern Time.
Early registration is recommended because seating is limited;
therefore, FDA may limit the number of participants from each
organization. Registrants will receive confirmation when they have been
accepted. If time and space permit, onsite registration on the day of
the public workshop will be provided beginning at 8 a.m. We will let
registrants know if registration closes before the day of the public
workshop.
If you need special accommodations due to a disability, please
contact Peggy Roney at Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5231,
Silver Spring, MD 20993-0002, 301-796-5671, email:
Peggy.Roney@fda.hhs.gov, no later than September 26, 2017.
Requests for Oral Presentations: During online registration you may
indicate if you wish to present during a public comment session or
participate in a specific session, and which topic(s) you wish to
address. We will do our best to accommodate requests to make public
comments and requests to participate in the focused sessions.
Individuals and organizations with common interests are urged to
consolidate or coordinate their presentations, and request time for a
joint presentation, or submit requests for designated representatives
to participate in the focused sessions. Following the close of
registration, we will determine the amount of time allotted to each
presenter and the approximate time each oral presentation is to begin,
and will select and notify participants by October 4, 2017. All
requests to make oral presentations must be received by the close of
registration on September 29, 2017. If selected for presentation, any
presentation materials must be emailed to the Francisco Vicenty (see
FOR FURTHER INFORMATION CONTACT) no
[[Page 34534]]
later than October 3, 2017. No commercial or promotional material will
be permitted to be presented or distributed at the public workshop.
Streaming webcast of the public workshop: This public workshop will
also be webcast. The webcast link will be available on the registration
Web page after October 3, 2017. Organizations are requested to register
all participants, but to view using one connection per location.
If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the Web site addresses in this document, as of the date this document
publishes in the Federal Register, but Web sites are subject to change
over time.
Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
Internet at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the
posted events list.)
IV. References
The following references are on display in the Dockets Management
Staff (see ADDRESSES), and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.
1. FDA's CDRH Case for Quality Initiative is available at:
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/MedicalDeviceQualityandCompliance/ucm378185.htm.
2. CDRH, 2016-2017 ``Promote a Culture of Quality and
Organizational Excellence'' available at: https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/UCM481588.pdf.
3. The Quality System regulation available at: https://www.ecfr.gov/cgi-bin/text-idx?SID=54a4a38f9c25eeab900b1c8f6c0f4212&mc=true&node=pt21.8.820&rgn=div5.
4. MDIC available at: https://mdic.org/.
5. CMMI system available at: https://cmmiinstitute.com/.
Dated: July 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15542 Filed 7-24-17; 8:45 am]
BILLING CODE 4164-01-P