Fostering Medical Innovation: Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program, 61575-61577 [2017-28044]

Download as PDF Federal Register / Vol. 82, No. 248 / Thursday, December 28, 2017 / Notices FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: December 21, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–27974 Filed 12–27–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–6778] Fostering Medical Innovation: Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration’s (FDA or Agency or we) Center for Devices and Radiological Health (CDRH or Center) is announcing its Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program (CfQ Pilot Program). The CfQ Pilot Program is voluntary and intends to evaluate product and manufacturing quality within the medical device ecosystem. The CfQ Pilot Program also intends to explore the effectiveness of a quality maturity appraisal, the use of objective metrics, optimization of resources, and impact on quality culture. The pilot program seeks to demonstrate better patient safety and outcomes, a lower regulatory burden on demonstrating quality assurance, and assure safety and effectiveness during product development and manufacturing. DATES: The CfQ Pilot Program will run from January 2, 2018, to December 28, 2018. See the ‘‘Participation’’ section for instructions on how to submit a request to participate. ADDRESSES: You may submit comments as follows: sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the VerDate Sep<11>2014 18:14 Dec 27, 2017 Jkt 244001 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–6778 for ‘‘Case for Quality Voluntary Medical Device Manufacturing and Product Quality 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. • 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 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 61575 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:// 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, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3426, Silver Spring, MD 20993, 301–796–5577, Francisco.vicenty@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background As part of CDRH’s 2016–2017 strategic priority to ‘‘Promote a Culture of Quality and Organizational Excellence’’ (Ref. 1), 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. Historically, FDA has evaluated manufacturers’ compliance with regulations governing the design and production of devices. Compliance with the Quality System regulation, 21 CFR part 820, (Ref. 2) is a baseline requirement for medical device manufacturing firms. Focusing on elevating manufacturing quality practices gives greater emphasis to these practices, which should correlate to higher quality outcomes. This allows FDA to adjust how we recognize and incentivize behaviors and processes through which the safety and effectiveness of a medical device is E:\FR\FM\28DEN1.SGM 28DEN1 sradovich on DSK3GMQ082PROD with NOTICES 61576 Federal Register / Vol. 82, No. 248 / Thursday, December 28, 2017 / Notices assured. CDRH intends to continue working with stakeholders to assess and promote manufacturers’ implementation of manufacturing quality practices in routine 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. 3) for this CfQ Pilot Program. The CMMI system is a process level improvement, training, and appraisal program. The CMMI Institute administers this program whose stated goal is to help organizations discover the true value they can deliver by building capability in their people and processes (Ref. 4). 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, identify any gaps, and recognize when a participating firm performs 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 independentassessments using a maturity model is intended to be a driver of continuous process and product improvement and add business value to voluntary participants in the CfQ Pilot Program. Assessments under the CMMI Institute are classified as Standard CMMI Appraisal Method for Process Improvement (SCAMPI) elements. A gap assessment (SCAMPI–C) will be a part of the CfQ 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. SCAMPI–C is intended to provide a rich dataset that reflects organizational performance and a comparison of the medical device manufacturer’s performance against the CMMI model. FDA is announcing and soliciting participation for the voluntary medical VerDate Sep<11>2014 18:14 Dec 27, 2017 Jkt 244001 device manufacturers CfQ Pilot Program. We intend to limit this voluntary pilot program to a maximum of nine participants. By participating in the third-party appraisal (SCAMPI–C), medical device manufacturers will receive an independent assessment of manufacturing and product quality intended to demonstrate sustained organizational excellence. By participating in the voluntary CfQ Pilot Program, FDA intends to forego conducting surveillance inspections. FDA will still conduct ‘‘For Cause’’ inspections where appropriate. The CMMI Institute will share the results of the SCAMPI–C appraisal with the manufacturer and develop a summary report to share with CDRH. Data collected through the appraisal and pilot will help inform FDA on how to modify its requirements around surveillance and preapproval inspections, as well as the content of premarket manufacturing submissions in order to better allocate resources and that could reduce the regulatory burden to appraised firms. The Center will continue an open dialog with the participants selected for the CfQ Pilot Program, medical device manufacturers and welcomes any feedback. For more information on the CfQ Pilot Program and how to enroll, please visit the website, http://mdic.org/cfq/enroll/. e. Allow for reporting to FDA by CMMI of analyzed performance data. A. Participation FDA seeks participation in the CfQ Pilot Program beginning January 2, 2018. The CfQ Pilot Program will select up to nine participants who provide a holistic representation of the medical device industry and meet the selection criteria. Companies that may be eligible to participate in this voluntary CfQ Pilot Program are limited to those firms following the procedures set out in section B and that also meet the selection qualities that follow: 1. The company must be in good compliance standing (No Action Indicated or Voluntary Action Indicated classification from FDA inspection or MDSAP (Medical Device Single Audit Program) audit within the last 5 years). 2. While participating in the CfQ Pilot Program, the company must agree to: a. Appraisal(s) conducted by the CMMI Institute. b. Collect and submit developed metric data and provide it to CMMI for analysis. Details and templates for the data are provided as part of the scoping discussions for the appraisal. c. Be available for real-time consultations with FDA and CMMI. d. Participate in established monitoring activities with CMMI. III. References PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 B. Procedures To be considered for the CfQ Pilot Program, a company should enroll at http://mdic.org/cfq/enroll/ or contact the CMMI Institute if you have questions at medicaldevice@ cmmiinstitute.com. Additional details of the proposed process for the CfQ Pilot Program can be found at the following website: http://mdic.org/cfq/enroll/. During this CfQ Pilot Program, CDRH staff intends to be available to answer questions or concerns that may arise. The CfQ Pilot Program participants may comment on and discuss their experiences throughout the process with the Center and CMMI Institute. II. Paperwork Reduction Act of 1995 This notice refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 820, regarding the Quality System regulations, have been approved under OMB control number 0910–0073. 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 website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time. 1. 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 and CDRH’s Case for Quality Initiative available at: https:// www.fda.gov/MedicalDevices/Device RegulationandGuidance/MedicalDevice QualityandCompliance/ucm378185.htm. 2. The Quality System regulation available at: https://www.ecfr.gov/cgi-bin/textidx?SID=54a4a38f9c25eeab900b1c8f6c 0f4212&mc=true&node=pt21.8.820&rgn= div5. 3. MDIC available at: http://mdic.org/. 4. CMMI system available at: http://cmmi institute.com/. E:\FR\FM\28DEN1.SGM 28DEN1 Federal Register / Vol. 82, No. 248 / Thursday, December 28, 2017 / Notices Dated: December 22, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–28044 Filed 12–27–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Council on Graduate Medical Education Health Resources and Service Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice of meeting. AGENCY: In accordance with the Federal Advisory Committee Act, this notice announces that the Council on Graduate Medical Education (COGME) will hold a public meeting. DATES AND TIME: January 29, 2018, 8:30 a.m.–5:00 p.m., and January 30, 2018, 8:30 a.m.–3:00 p.m. ET. ADDRESSES: The address for the meeting is 5600 Fishers Lane, Rockville, Maryland 20857. Participants may also access the meeting through teleconference and webinar. • The teleconference call-in number is 1–800–619–2521, passcode: 9271697. • The webinar link is https:// hrsa.connectsolutions.com/cogmecouncil/. FOR FURTHER INFORMATION CONTACT: Anyone requesting information regarding COGME should contact Kennita R. Carter, MD, Designated Federal Officer, Division of Medicine and Dentistry, Bureau of Health Workforce, HRSA, in one of three ways: (1) Send a request to the following address: Dr. Kennita R. Carter, Designated Federal Officer, Division of Medicine and Dentistry, HRSA, 5600 Fishers Lane, 15N–116, Rockville, Maryland 20857; (2) call 301–945–3505; or (3) send an email to KCarter@ hrsa.gov. SUPPLEMENTARY INFORMATION: COGME provides advice and recommendations to the Secretary of HHS and to Congress on a range of issues, including the nature and financing of medical education training, the development of performance measures and longitudinal evaluation methods of medical education programs, foreign medical school graduates, and the supply and distribution of the physician workforce in the United States, including any projected shortages or excesses. During the meeting, the COGME members will discuss the strategic sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:14 Dec 27, 2017 Jkt 244001 directions of the Council and issues related to physician workforce development and graduate medical education, leading to the selection of a topic for its 24th Report to Congress. COGME submits its reports to the Secretary of HHS; the Senate Committee on Health, Education, Labor, and Pensions; and the House of Representatives Committee on Energy and Commerce. COGME will also discuss the HRSA proposal for a quality bonus system of payments for eligible hospitals within the Children’s Hospital Graduate Medical Education (CHGME) program. HRSA will post the agenda on the COGME website at http://www.hrsa.gov/ advisorycommittees/bhpradvisory/ COGME prior to the meeting. Please note that agenda items are subject to change as priorities dictate. Members of the public will have the opportunity to provide comments and may submit written statements in advance of the meeting. The committee will honor oral comments in the order requested and may be limited as time allows. Public participants should send requests to provide written statements or make oral comments to the COGME to Kennita R. Carter, MD, Designated Federal Officer, using the contact information above, at least three business days prior to the meeting. The building at 5600 Fishers Lane, Rockville, MD 20857, requires a security screening for entry. To facilitate access to the building, individuals interested in attending the meeting should notify Dr. Kennita Carter at the contact information listed above at least three business days prior to the meeting. Individuals who plan to attend and who need special assistance, such as sign language interpretation or other reasonable accommodations, should notify Dr. Kennita Carter at the contact information listed above at least 10 business days prior to the meeting. Amy McNulty, Acting Director, Division of the Executive Secretariat. [FR Doc. 2017–28015 Filed 12–27–17; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. PO 00000 Frm 00045 Fmt 4703 The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Eye Institute Special Emphasis Panel; Brain Initiative (R21) Review: New Concepts and Early-Stage Research for Large-Scale Recording and Modulation In The Nervous System. Date: January 22, 2018. Time: 8:30 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Garden Inn Bethesda, 7301 Waverly Street, Bethesda, MD 20814. Contact Person: Brian Hoshaw, Ph.D., Scientific Review Officer, National Eye Institute, National Institutes of Health, Division of Extramural Research, 5635 Fishers Lane, Suite 1300, Rockville, MD 20892, 301–451–2020, hoshawb@ mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.867, Vision Research, National Institutes of Health, HHS) Dated: December 21, 2017. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–27936 Filed 12–27–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS–HQ–R–2017–N118]; [FXGO1664091HCC0–FF09D00000–178] Hunting and Shooting Sports Conservation Council Establishment; Request for Nominations Fish and Wildlife Service, Interior. ACTION: Notice. AGENCY: The U.S. Department of the Interior (DOI) is establishing and seeking nominations for the Hunting and Shooting Sports Conservation Council (Council). The Council will provide recommendations to the Federal Government, through the Secretary of the Interior (Secretary) and the Secretary of Agriculture, regarding the establishment and implementation of existing and proposed policies and authorities with regard to wildlife and habitat conservation endeavors that: Benefit wildlife resources; encourage SUMMARY: BILLING CODE 4165–15–P Sfmt 4703 61577 E:\FR\FM\28DEN1.SGM 28DEN1

Agencies

[Federal Register Volume 82, Number 248 (Thursday, December 28, 2017)]
[Notices]
[Pages 61575-61577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-28044]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6778]


Fostering Medical Innovation: Case for Quality Voluntary Medical 
Device Manufacturing and Product Quality Pilot Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration's (FDA or Agency or we) 
Center for Devices and Radiological Health (CDRH or Center) is 
announcing its Case for Quality Voluntary Medical Device Manufacturing 
and Product Quality Pilot Program (CfQ Pilot Program). The CfQ Pilot 
Program is voluntary and intends to evaluate product and manufacturing 
quality within the medical device ecosystem. The CfQ Pilot Program also 
intends to explore the effectiveness of a quality maturity appraisal, 
the use of objective metrics, optimization of resources, and impact on 
quality culture. The pilot program seeks to demonstrate better patient 
safety and outcomes, a lower regulatory burden on demonstrating quality 
assurance, and assure safety and effectiveness during product 
development and manufacturing.

DATES: The CfQ Pilot Program will run from January 2, 2018, to December 
28, 2018. See the ``Participation'' section for instructions on how to 
submit a request to participate.

ADDRESSES: You may submit comments 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-2017-N-6778 for ``Case for Quality Voluntary Medical Device 
Manufacturing and Product Quality 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.
     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, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 3426, Silver Spring, MD 20993, 301-796-
5577, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    As part of CDRH's 2016-2017 strategic priority to ``Promote a 
Culture of Quality and Organizational Excellence'' (Ref. 1), 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. 
Historically, FDA has evaluated manufacturers' compliance with 
regulations governing the design and production of devices. Compliance 
with the Quality System regulation, 21 CFR part 820, (Ref. 2) is a 
baseline requirement for medical device manufacturing firms. Focusing 
on elevating manufacturing quality practices gives greater emphasis to 
these practices, which should correlate to higher quality outcomes. 
This allows FDA to adjust how we recognize and incentivize behaviors 
and processes through which the safety and effectiveness of a medical 
device is

[[Page 61576]]

assured. CDRH intends to continue working with stakeholders to assess 
and promote manufacturers' implementation of manufacturing quality 
practices in routine 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. 3) for this 
CfQ Pilot Program. The CMMI system is a process level improvement, 
training, and appraisal program. The CMMI Institute administers this 
program whose stated goal is to help organizations discover the true 
value they can deliver by building capability in their people and 
processes (Ref. 4). 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, identify any gaps, and recognize when a 
participating firm performs 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 add 
business value to voluntary participants in the CfQ Pilot Program.
    Assessments under the CMMI Institute are classified as Standard 
CMMI Appraisal Method for Process Improvement (SCAMPI) elements. A gap 
assessment (SCAMPI-C) will be a part of the CfQ 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. SCAMPI-C is intended to provide a rich dataset that reflects 
organizational performance and a comparison of the medical device 
manufacturer's performance against the CMMI model.
    FDA is announcing and soliciting participation for the voluntary 
medical device manufacturers CfQ Pilot Program. We intend to limit this 
voluntary pilot program to a maximum of nine participants. By 
participating in the third-party appraisal (SCAMPI-C), medical device 
manufacturers will receive an independent assessment of manufacturing 
and product quality intended to demonstrate sustained organizational 
excellence. By participating in the voluntary CfQ Pilot Program, FDA 
intends to forego conducting surveillance inspections. FDA will still 
conduct ``For Cause'' inspections where appropriate. The CMMI Institute 
will share the results of the SCAMPI-C appraisal with the manufacturer 
and develop a summary report to share with CDRH. Data collected through 
the appraisal and pilot will help inform FDA on how to modify its 
requirements around surveillance and preapproval inspections, as well 
as the content of premarket manufacturing submissions in order to 
better allocate resources and that could reduce the regulatory burden 
to appraised firms. The Center will continue an open dialog with the 
participants selected for the CfQ Pilot Program, medical device 
manufacturers and welcomes any feedback. For more information on the 
CfQ Pilot Program and how to enroll, please visit the website, http://mdic.org/cfq/enroll/.

A. Participation

    FDA seeks participation in the CfQ Pilot Program beginning January 
2, 2018. The CfQ Pilot Program will select up to nine participants who 
provide a holistic representation of the medical device industry and 
meet the selection criteria.
    Companies that may be eligible to participate in this voluntary CfQ 
Pilot Program are limited to those firms following the procedures set 
out in section B and that also meet the selection qualities that 
follow:
    1. The company must be in good compliance standing (No Action 
Indicated or Voluntary Action Indicated classification from FDA 
inspection or MDSAP (Medical Device Single Audit Program) audit within 
the last 5 years).
    2. While participating in the CfQ Pilot Program, the company must 
agree to:
    a. Appraisal(s) conducted by the CMMI Institute.
    b. Collect and submit developed metric data and provide it to CMMI 
for analysis. Details and templates for the data are provided as part 
of the scoping discussions for the appraisal.
    c. Be available for real-time consultations with FDA and CMMI.
    d. Participate in established monitoring activities with CMMI.
    e. Allow for reporting to FDA by CMMI of analyzed performance data.

B. Procedures

    To be considered for the CfQ Pilot Program, a company should enroll 
at http://mdic.org/cfq/enroll/ or contact the CMMI Institute if you 
have questions at [email protected]. Additional details 
of the proposed process for the CfQ Pilot Program can be found at the 
following website: http://mdic.org/cfq/enroll/.
    During this CfQ Pilot Program, CDRH staff intends to be available 
to answer questions or concerns that may arise. The CfQ Pilot Program 
participants may comment on and discuss their experiences throughout 
the process with the Center and CMMI Institute.

II. Paperwork Reduction Act of 1995

    This notice refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 820, regarding the Quality 
System regulations, have been approved under OMB control number 0910-
0073.

III. 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 website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.

1. 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 and CDRH's Case for Quality 
Initiative available at: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/MedicalDeviceQualityandCompliance/ucm378185.htm.
2. The Quality System regulation available at: https://www.ecfr.gov/cgi-bin/text-idx?SID=54a4a38f9c25eeab900b1c8f6c0f4212&mc=true&node=pt21.8.820&rgn=div5.
3. MDIC available at: http://mdic.org/.
4. CMMI system available at: http://cmmiinstitute.com/.


[[Page 61577]]


    Dated: December 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-28044 Filed 12-27-17; 8:45 am]
 BILLING CODE 4164-01-P