Breakthrough Devices Program; Guidance for Industry and Food and Drug Administration Staff; Availability, 63582-63584 [2023-20007]

Download as PDF 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, ddrumheller on DSK120RN23PROD with NOTICES1 HHS. ACTION: Notice of availability. 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 SUMMARY: VerDate Sep<11>2014 17:05 Sep 14, 2023 Jkt 259001 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 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 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-201509-18/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 E:\FR\FM\15SEN1.SGM 15SEN1 Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices 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 ddrumheller on DSK120RN23PROD with NOTICES1 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. 63583 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: OMB control No. 21 CFR part or guidance Topic 807, subpart E ............................................................................ 814, subparts A through E .......................................................... 812 .............................................................................................. 860, subpart D ............................................................................ ‘‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’’. 822 .............................................................................................. 820 .............................................................................................. Premarket notification ................................................................ Premarket approval .................................................................... Investigational Device Exemption .............................................. De Novo classification process .................................................. Q-submissions ........................................................................... 0910–0120 0910–0231 0910–0078 0910–0844 0910–0756 Postmarket Surveillance of Medical Devices ............................ Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation. 0910–0449 0910–0073 VerDate Sep<11>2014 17:05 Sep 14, 2023 Jkt 259001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\15SEN1.SGM 15SEN1 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. 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. SUMMARY: 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: ddrumheller on DSK120RN23PROD with NOTICES1 DATES: 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:// VerDate Sep<11>2014 17:05 Sep 14, 2023 Jkt 259001 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 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 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-201509-18/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 E:\FR\FM\15SEN1.SGM 15SEN1

Agencies

[Federal Register Volume 88, Number 178 (Friday, September 15, 2023)]
[Notices]
[Pages 63582-63584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20007]


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

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

[[Page 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 self-
addressed 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 life-threatening 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-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 or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of 
``Breakthrough Guidance Program'' may send an email request to [email protected] 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:

------------------------------------------------------------------------
                                                            OMB control
    21 CFR part or guidance               Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket notification.       0910-0120
814, subparts A through E......  Premarket approval.....       0910-0231
812............................  Investigational Device        0910-0078
                                  Exemption.
860, subpart D.................  De Novo classification        0910-0844
                                  process.
``Requests for Feedback and      Q-submissions..........       0910-0756
 Meetings for Medical Device
 Submissions: The Q-Submission
 Program''.
822............................  Postmarket Surveillance       0910-0449
                                  of Medical Devices.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
------------------------------------------------------------------------



[[Page 63584]]

    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

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