[Federal Register Volume 83, Number 243 (Wednesday, December 19, 2018)]
[Notices]
[Pages 65169-65171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27433]


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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 the final guidance entitled ``Breakthrough Devices 
Program; Guidance for Industry and Food and Drug Administration 
Staff.'' This guidance document describes policies that FDA intends to 
use to implement the new Breakthrough Devices Program, established by 
the 21st Century Cures Act (Cures Act). The Breakthrough Devices 
Program supersedes and combines elements from FDA's Expedited Access 
Pathway (EAP), which was intended to facilitate the development and 
expedite review of certain devices that demonstrate the potential to 
address unmet medical needs, as well as the Priority Review Program, 
which implemented statutory criteria for granting priority review to 
premarket approval applications (PMAs) and applied those criteria to 
other types of premarket submissions for medical devices. This guidance 
is intended to clarify certain principles and features of the new 
program, the designation criteria for Breakthrough Devices, the 
designation request review process, the process for withdrawing from 
the program, as well as the recommended information device 
manufacturers should provide in their designation request for entrance 
into the program.

DATES: The announcement of the guidance is published in the Federal 
Register on December 19, 2018.

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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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; Guidance for 
Industry and Food and Drug Administration Staff.'' 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.
    <bullet> 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.gpo.gov/fdsys/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.
    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

[[Page 65170]]

information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Breakthrough Devices Program; Guidance for Industry and Food and Drug 
Administration Staff'' to the Office of the Center Director, Guidance 
and Policy Development, 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: Maureen Dreher, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm.1545, Silver Spring, MD 20993-0002, 301-796-2505.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is issuing this guidance to describe policies that FDA intends 
to use to implement section 515B of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 360e-3, as created by section 3051 
of the Cures Act (Pub. L. 114-255) and amended by section 901 of the 
FDA Reauthorization Act of 2017 (Pub. L. 115-52) (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. This 
program is intended to help patients have more timely access to these 
medical devices by expediting their development, assessment, and 
review, while preserving the statutory standards for premarket 
approval, premarket notification (510(k)) clearance, and De Novo 
marketing authorization, consistent with the Agency's mission to 
protect and promote public health.
    As part of the Breakthrough Devices Program, FDA intends to provide 
interactive and timely communication with the sponsor during 
development and throughout the review process for devices designated as 
Breakthrough Devices under section 515B(d)(1) of the FD&C Act and 
prioritize the review of associated Q-submissions, investigational 
device exemption (IDE) applications, PMAs, certain PMA supplements, De 
Novo requests, and/or 510(k)s. In addition, for Breakthrough Devices 
subject to PMA, FDA may consider the amount and nature of data that may 
be collected in the postmarket setting, rather than premarket, and the 
extent of uncertainty that may be appropriate in the benefit-risk 
profile at the time of approval. Getting the right balance between 
premarket and postmarket data collection--specifically, where 
appropriate, a greater reliance on postmarket collection--can reduce 
the extent of premarket data submission. Collectively, these and the 
other principles of the program described in this guidance are intended 
to support a least-burdensome approach for expediting patient access to 
Breakthrough Devices.
    The Breakthrough Devices Program supersedes the EAP, which launched 
in 2015. The Breakthrough Devices Program contains features of the EAP 
as well as the Innovation Pathway (first piloted in 2011; pilot is now 
discontinued), both of which were intended to facilitate the 
development and expedite the review of breakthrough technologies.
    The Breakthrough Devices Program also supersedes the Priority 
Review Program, which implemented statutory criteria for granting 
priority review to PMA submissions for medical devices, applied those 
criteria to other types of premarket submissions for medical devices, 
and included standard procedures to achieve an efficient priority 
review process.
    FDA considered comments received on the draft guidance that 
appeared in the Federal Register of October 25, 2017. FDA revised the 
guidance as appropriate in response to the comments. This document 
supersedes the guidance document ``Expedited Access for Premarket 
Approval and De Novo Medical Devices Intended for Unmet Medical Need 
for Life Threatening or Irreversibly Debilitating Diseases or 
Conditions,'' issued on April 13, 2015.

II. Significance of Guidance

    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; Guidance 
for Industry and Food and Drug Administration Staff.'' 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. This guidance 
is not subject to Executive Order 12866.

III. 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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This 
guidance document is also available at https://www.regulations.gov. 
Persons unable to download an electronic copy of ``Breakthrough Devices 
Program; Guidance for Industry and Food and Drug Administration Staff'' 
may send an email request to <a href="/cdn-cgi/l/email-protection#5f1c1b0d1772182a363b3e313c3a1f393b3e7137372c71383029"><span class="__cf_email__" data-cfemail="5e1d1a0c1673192b373a3f303d3b1e383a3f7036362d70393128">[email protected]</span></a> to receive an 
electronic copy of the document. Please use the document number 1833 to 
identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 
the following FDA regulations and guidance have been approved by OMB as 
listed in the following table:

------------------------------------------------------------------------
 21 CFR part; guidance; or FDA                              OMB control
              form                        Topic                 No.
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807, subpart E.................  Premarket notification.       0910-0120
814, subparts A through E......  Premarket approval.....       0910-0231
814, subpart H.................  Humanitarian Device           0910-0332
                                  Exemption.
812............................  Investigational Device        0910-0078
                                  Exemption.
``De Novo Classification         De Novo classification        0910-0844
 Process (Evaluation of           process.
 Automatic Class III
 Designation)''.
``Requests for Feedback on       Q-submissions..........       0910-0756
 Medical Device Submissions:
 The Pre-Submission Program and
 Meetings with Food and Drug
 Administration Staff''.

[[Page 65171]]

 
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
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    Dated: December 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-27433 Filed 12-18-18; 8:45 am]
 BILLING CODE 4164-01-P


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