[Federal Register Volume 88, Number 178 (Friday, September 15, 2023)]
[Notices]
[Pages 63584-63586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20016]


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

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.

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

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:
     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-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 https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     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.govinfo.gov/content/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, 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\
---------------------------------------------------------------------------

    \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 https://www.federalregister.gov/documents/2022/02/23/2022-03227/medical-devices-quality-system-regulation-amendments). 
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.
---------------------------------------------------------------------------

    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 https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/voluntary-medical-device-manufacturing-and-product-quality-pilot-program.
    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 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents. 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 [email protected] 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:

------------------------------------------------------------------------
                                                            OMB control
21 CFR part; Guidance; or FDA form          Topic               No.
------------------------------------------------------------------------
``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.
------------------------------------------------------------------------


    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