82 FR 61575 - Fostering Medical Innovation: Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 248 (December 28, 2017)

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.

[Federal Register Volume 82, Number 248 (Thursday, December 28, 2017)]
[Notices]
[Pages 61575-61577]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-28044]


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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.

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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.thefederalregister.org/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/.


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    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