[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:
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; 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.
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 [email protected] 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:
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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''.
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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]
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