[Federal Register Volume 82, Number 141 (Tuesday, July 25, 2017)]
[Pages 34531-34534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15542]



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 
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: [email protected].


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 
    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 
    [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 
    [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 
    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: 
[email protected], 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 

[[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 http://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: 
    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: http://mdic.org/.
    5. CMMI system available at: http://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]