63584 Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices 

Dated: September 12, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20007 Filed 9–14–23; 8:45 am] 

BILLING CODE 4164–01–P 

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 thirdparty 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 selfaddressed 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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices 63585 

1On 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-systemregulation-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. 

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

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-medicaldevices/voluntary-medical-devicemanufacturing-and-product-qualitypilot-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-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-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 CDRH-Guidance@

fda.hhs.gov 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: 

21 CFR part; Guidance; or FDA form Topic OMB 

control No. 

‘‘Fostering Medical Device Improvement: Food and Drug Administration Activities and Engagement with the Voluntary 

Improvement Program’’.

Voluntary Improvement Program (VIP) ...................................... 0910–0922 

807, subpart E ............................................................................ Premarket notification ................................................................. 0910–0120 

7 .................................................................................................. Recalls ........................................................................................ 0910–0432 

814, subparts A through E ......................................................... Premarket approval .................................................................... 0910–0231 

814, subpart H ............................................................................ Humanitarian Device Exemption ................................................ 0910–0332 

860, subpart D ............................................................................ De Novo classification process .................................................. 0910–0844 

803 .............................................................................................. Medical Device Reporting .......................................................... 0910–0437 


ddrumheller on DSK120RN23PROD with NOTICES1
63586 Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices 

21 CFR part; Guidance; or FDA form Topic OMB 

control No. 

806 .............................................................................................. Medical Devices; Reports of Corrections and Removals .......... 0910–0359 

820 .............................................................................................. Current Good Manufacturing Practice (CGMP); Quality System 

(QS) Regulation.

0910–0073 

807, subparts A through D ......................................................... Medical Device Registration and Listing .................................... 0910–0625 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–2654] 

Informed Consent Forms for Studies 

that Enroll Client-Owned Companion 

Animals; Draft Guidance for Industry; 

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 draft 

guidance for industry (GFI) #282 

entitled ‘‘Informed Consent Forms for 

Studies that Enroll Client-Owned 

Companion Animals.’’ As used in this 

guidance, informed consent is a 

documented process by which an owner 

or owner’s agent voluntarily confirms 

the owner’s willingness to allow their 

animal(s) to participate in a particular 

study, after having been informed of all 

aspects of the study that may be relevant 

to the owner’s decision to participate. A 

sponsor or investigator should ensure 

the owner is provided with adequate 

information and time to allow for an 

informed decision about voluntary 

participation in a clinical investigation. 

This draft guidance provides 

recommendations on informed consent 

forms (ICF) used for studies that enroll 

client-owned companion animals (dogs, 

cats, and horses). FDA’s Center for 

Veterinary Medicine (CVM) 

recommends all studies conducted with 

client-owned companion animals use an 

ICF and be conducted in accordance 

with Good Clinical Practice (GCP) 

guidelines. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by November 14, 2023 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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– 

2023–D–2654 for ‘‘Informed Consent 

Forms for Studies that Enroll ClientOwned Companion Animals.’’ 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)). 

Submit written requests for single 

copies of the guidance to the Policy and 

Regulations Staff (HFV–6), Center for 

Veterinary Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 


ddrumheller on DSK120RN23PROD with NOTICES1