63582 Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices 

Report Information and Other 

Submissions for Postmarketing 

Requirements and Commitments: Using 

Forms FDA 3988 and FDA 3989.’’ 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. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information 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 collections of 

information for applicants required to 

submit ASRs on PMCs and PMRs under 

section 506B of the FD&C Act and the 

implementing regulations at 

§§ 314.81(b)(2)(vii) and 601.70 are 

approved under OMB control numbers 

0910–0001 and 0910–0338, respectively. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: September 12, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20014 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–2017–D–5966] 

Breakthrough Devices 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 ‘‘Breakthrough 

Devices Program.’’ This final guidance 

describes policies that FDA intends to 

use to implement a section of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act). This guidance updates the 

previous version of the guidance, of the 

same title, issued on December 18, 2018, 

and describes how the Breakthrough 

Devices Program may also be applicable 

to certain devices that benefit 

populations impacted by health and/or 

healthcare disparities. Consistent with 

our obligations under the SUPPORT for 

Patients and Communities Act 

(SUPPORT Act), the Breakthrough 

Devices Program may be available for 

certain non-addictive medical products 

to treat pain or addiction. 

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– 

2017–D–5966 for ‘‘Breakthrough 

Devices 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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices 63583 

single hard copy of the guidance 

document entitled ‘‘Breakthrough 

Devices 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: 

Ouided Rouabhi, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. G221, Silver Spring, 

MD 20993–0002, 240–402–2672; or 

Anne Taylor, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993, 240–402– 

7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a final guidance entitled ‘‘Breakthrough 

Devices Program.’’ The document 

describes policies that FDA intends to 

use to implement section 515B of the 

FD&C Act (21 U.S.C. 360e–3), as created 

by section 3051 of the 21st Century 

Cures Act (Cures Act) (Pub. L. 114–255), 

amended by section 901 of the FDA 

Reauthorization Act of 2017 (Pub. L. 

115–52), and amended by section 3001 

of the SUPPORT for Patients and 

Communities Act (Pub. L. 115–271) (the 

‘‘Breakthrough Devices Program’’). The 

Breakthrough Devices Program is a 

voluntary program for certain medical 

devices and device-led combination 

products that provide for more effective 

treatment or diagnosis of lifethreatening or irreversibly debilitating 

diseases or conditions. It is available for 

devices and device-led combination 

products that are subject to review 

under a premarket approval application 

(PMA), premarket notification (510(k)), 

or De Novo classification request (‘‘De 

Novo request’’). 

The Breakthrough Devices Program 

may also be applicable to certain 

devices that benefit populations 

impacted by health and/or healthcare 

disparities, thereby promoting and 

advancing health equity. In addition, 

consistent with our obligations under 

section 3001 of the SUPPORT Act, the 

Breakthrough Devices Program may be 

available for certain non-addictive 

medical products to treat pain or 

addiction (section 515B of the FD&C 

Act). The considerations set forth in the 

guidance document apply to FDA’s 

review of devices as non-addictive 

methods to treat pain or addiction. This 

program is intended to help patients 

have more timely access to designated 

medical devices, including those that 

provide for more effective treatment or 

diagnosis of life-threatening or 

irreversibly debilitating diseases or 

conditions in populations impacted by 

health and/or healthcare disparities, by 

expediting their development, 

assessment, and review, while 

preserving the statutory standards for 

PMAs, 510(k) clearance, and De Novo 

marketing authorization, consistent with 

the Agency’s mission to protect and 

promote public health. 

This guidance finalizes the draft 

guidance entitled ‘‘Select Updates for 

the Breakthrough Devices Program 

Guidance: Reducing Disparities in 

Health and Healthcare.’’ A notice of 

availability of the draft guidance 

appeared in the Federal Register of 

October 21, 2022 (87 FR 64057). FDA 

considered comments received and 

revised the guidance as appropriate in 

response to comments, including further 

clarifying FDA’s intent to consider 

technologies and device features that 

may help to address health and/or 

healthcare disparities and promote 

health equity by providing for more 

effective treatment or diagnosis in 

various populations that exhibit health 

and healthcare disparities. FDA did not 

substantively change the sections of the 

existing Breakthrough Devices Program 

guidance that were not affected by the 

select update. 

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 the ‘‘Breakthrough 

Devices 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 or 

https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics. 

Persons unable to download an 

electronic copy of ‘‘Breakthrough 

Guidance 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 GUI00001833 and complete 

title to identify the guidance you are 

requesting. 

III. Paperwork Reduction Act of 1995 

While this guidance contains no new 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information 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 collections of 

information in the following table have 

been approved by OMB: 

21 CFR part or guidance Topic OMB control 

No. 

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

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

812 .............................................................................................. Investigational Device Exemption .............................................. 0910–0078 

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

‘‘Requests for Feedback and Meetings for Medical Device 

Submissions: The Q-Submission Program’’.

Q-submissions ........................................................................... 0910–0756 

822 .............................................................................................. Postmarket Surveillance of Medical Devices ............................ 0910–0449 

820 .............................................................................................. Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation.0910–0073 


ddrumheller on DSK120RN23PROD with NOTICES1
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