Notice2023-20016
Fostering Medical Device Improvement: Food and Drug Administration Activities and Engagement With the Voluntary Improvement Program; Guidance for Industry and Food and Drug Administration Staff; Availability
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Published
September 15, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Fostering Medical Device Improvement: Food and Drug Administration Activities and Engagement with the Voluntary Improvement Program." FDA is issuing this guidance to describe its policy regarding FDA's participation in the Voluntary Improvement Program (VIP). The VIP is a voluntary program facilitated through the Medical Device Innovation Consortium (MDIC) that evaluates the capability and performance of a medical device manufacturer's practices using third-party appraisals, and is intended to guide improvement to enhance the quality of devices. The VIP builds on the framework piloted through FDA's 2018 Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program (CfQ Pilot Program) and incorporates some of the successes and learnings from the pilot.
Full Text
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<title>Federal Register, Volume 88 Issue 178 (Friday, September 15, 2023)</title>
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[Federal Register Volume 88, Number 178 (Friday, September 15, 2023)]
[Notices]
[Pages 63584-63586]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-20016]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-0109]
Fostering Medical Device Improvement: Food and Drug
Administration Activities and Engagement With the Voluntary Improvement
Program; Guidance for Industry and Food and Drug Administration Staff;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Fostering Medical
Device Improvement: Food and Drug Administration Activities and
Engagement with the Voluntary Improvement Program.'' FDA is issuing
this guidance to describe its policy regarding FDA's participation in
the Voluntary Improvement Program (VIP). The VIP is a voluntary program
facilitated through the Medical Device Innovation Consortium (MDIC)
that evaluates the capability and performance of a medical device
manufacturer's practices using third-party appraisals, and is intended
to guide improvement to enhance the quality of devices. The VIP builds
on the framework piloted through FDA's 2018 Case for Quality Voluntary
Medical Device Manufacturing and Product Quality Pilot Program (CfQ
Pilot Program) and incorporates some of the successes and learnings
from the pilot.
DATES: The announcement of the guidance is published in the Federal
Register on September 15, 2023.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2022-D-0109 for ``Fostering Medical Device Improvement: Food and
Drug Administration Activities and Engagement with the Voluntary
Improvement Program.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Fostering Medical Device Improvement: Food and Drug Administration
Activities and Engagement with the Voluntary Improvement Program'' to
the Office of Policy, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.
FOR FURTHER INFORMATION CONTACT: Francisco Vicenty, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1534, Silver Spring, MD 20993-0002, 301-
796-5577.
SUPPLEMENTARY INFORMATION:
I. Background
As part of the Center for Devices and Radiological Health's
(CDRH's) 2016-2017 strategic priority to ``Promote a Culture of Quality
and Organizational Excellence,'' CDRH envisions a future where the
medical device ecosystem is
[[Page 63585]]
inherently focused on device features and manufacturing practices that
have the greatest impact on product quality and patient safety. Among
its other regulatory activities, FDA evaluates manufacturers'
compliance with regulations governing the design and production of
devices. Compliance with the ``Quality System Regulation,'' 21 CFR part
820, is a baseline requirement for medical device manufacturing
firms.\1\
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\1\ On February 23, 2022, FDA proposed to amend the device QS
regulation, 21 CFR part 820, to align more closely with
international consensus standards for devices (87 FR 10119;
available at <a href="https://www.federalregister.gov/documents/2022/02/23/2022-03227/medical-devices-quality-system-regulation-amendments">https://www.federalregister.gov/documents/2022/02/23/2022-03227/medical-devices-quality-system-regulation-amendments</a>).
Specifically, FDA proposed to withdraw the majority of the current
requirements in part 820 and instead incorporate by reference the
2016 edition of the International Organization for Standardization
(ISO) 13485, Medical devices--Quality management systems for
regulatory purposes, in part 820. As stated in that proposed rule,
the requirements in ISO 13485 are, when taken in totality,
substantially similar to the requirements of the current part 820,
providing a similar level of assurance in a firm's quality
management system and ability to consistently manufacture devices
that are safe and effective and otherwise in compliance with the
FD&C Act. FDA intends to finalize this proposed rule expeditiously.
When the final rule takes effect, FDA will also update the
references to provisions in 21 CFR part 820 in this guidance to be
consistent with that rule.
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In an effort to elevate and enhance manufacturing practices and
behaviors through which quality and safety of medical devices can be
improved, FDA has collaborated with various stakeholders, brought
together through the MDIC public-private partnership, to develop the
CfQ Pilot Program. FDA announced the voluntary CfQ Pilot Program in the
Federal Register on December 28, 2017 (82 FR 61575).
As in the CfQ Pilot Program, the VIP oversees third-party
appraisers who evaluate voluntary industry participants, and the VIP
assesses the capability and performance of key business processes using
a series of integrated best practices. Those practices are detailed in
the Information Systems Audit and Control Association Capability
Maturity Model Integration (CMMI) system. CMMI provides a roadmap that
guides improvement toward disciplined and consistent processes for
achieving key business objectives, including quality and performance.
The VIP uses a version of the CMMI appraisal appropriate for the
medical device industry. This appraisal tool is referred to as the
Medical Device Discovery Appraisal Program (MDDAP) model. The baseline
appraisal using the MDDAP model covers 11 practices areas, such as
Governance, Implementation Infrastructure, and Managing Performance and
Measurement. Subsequent appraisals may include an alternate list of
practice areas compared to the baseline set. As part of the VIP, and as
in the CfQ Pilot Program, the program provides firms and FDA with
information about the firm's capability and performance for activities
covered in the third-party appraisal.
Details and results from the 2018 CfQ Pilot Program are outlined in
MDIC's Case for Quality Pilot Report, available at <a href="https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/voluntary-medical-device-manufacturing-and-product-quality-pilot-program">https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/voluntary-medical-device-manufacturing-and-product-quality-pilot-program</a>.
This voluntary program is currently only available to eligible
manufacturers of medical devices regulated by CDRH and whose marketing
applications are reviewed under the applicable provisions of the
Federal Food, Drug, and Cosmetic Act (including under sections 510(k),
513, 515, and 520) (21 U.S.C. 360(k), 360c, 360e, and 360j).
A notice of availability of the draft guidance appeared in the
Federal Register of May 6, 2022 (87 FR 27165). FDA considered comments
received and revised the guidance as appropriate in response to the
comments, including clarifying what participants must demonstrate to
benefit from the opportunities offered by VIP, explaining that program
participation is not a substitute for an FDA inspection, and providing
further detail regarding the role of FDA in VIP.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on Fostering Medical Device Improvement: Food
and Drug Administration Activities and Engagement with the Voluntary
Improvement Program. It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.
II. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This guidance document is also
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. Persons unable to
download an electronic copy of ``Fostering Medical Device Improvement:
Food and Drug Administration Activities and Engagement with the
Voluntary Improvement Program'' may send an email request to <a href="/cdn-cgi/l/email-protection#b6f5f2e4fe9bf1c3dfd2d7d8d5d3f6d0d2d798dedec598d1d9c0"><span class="__cf_email__" data-cfemail="b5f6f1e7fd98f2c0dcd1d4dbd6d0f5d3d1d49bddddc69bd2dac3">[email protected]</span></a> to receive an electronic copy of the document.
Please use the document number GUI00020039 and complete title to
identify the guidance you are requesting.
III. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The
guidance also refers to previously approved FDA collections of
information which are also subject to review by OMB under the PRA. The
collections of information in the following FDA regulations, guidance,
and forms have been approved by OMB as listed in the following table:
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OMB control
21 CFR part; Guidance; or FDA form Topic No.
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``Fostering Medical Device Voluntary 0910-0922
Improvement: Food and Drug Improvement Program
Administration Activities and (VIP).
Engagement with the Voluntary
Improvement Program''.
807, subpart E.................... Premarket 0910-0120
notification.
7................................. Recalls............. 0910-0432
814, subparts A through E......... Premarket approval.. 0910-0231
814, subpart H.................... Humanitarian Device 0910-0332
Exemption.
860, subpart D.................... De Novo 0910-0844
classification
process.
803............................... Medical Device 0910-0437
Reporting.
[[Page 63586]]
806............................... Medical Devices; 0910-0359
Reports of
Corrections and
Removals.
820............................... Current Good 0910-0073
Manufacturing
Practice (CGMP);
Quality System (QS)
Regulation.
807, subparts A through D......... Medical Device 0910-0625
Registration and
Listing.
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Dated: September 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20016 Filed 9-14-23; 8:45 am]
BILLING CODE 4164-01-P
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