
[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]


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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.

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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:

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                                                            OMB control
    21 CFR part or guidance               Topic                 No.
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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.
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[[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


