82 FR 49373 - Breakthrough Devices Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 205 (October 25, 2017)

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Breakthrough Devices Program; Draft Guidance for Industry and Food and Drug Administration Staff.''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 breakthrough technologies, 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 This draft guidance clarifies certain principles and features of the new program, the designation criteria for Breakthrough Devices, the designation request review process, the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. This draft guidance is not final nor is it in effect at this time.

[Federal Register Volume 82, Number 205 (Wednesday, October 25, 2017)]
[Notices]
[Pages 49373-49375]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-23195]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5966]


Breakthrough Devices Program; Draft Guidance for Industry and 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the availability of the draft guidance entitled ``Breakthrough Devices 
Program; Draft Guidance for Industry and Food and Drug Administration 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 breakthrough technologies, 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 draft guidance clarifies 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. This draft guidance is not final nor is it in effect 
at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by December 26, 2017 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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.

[[Page 49374]]

     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; Draft 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.thefederalregister.org/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 information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document entitled 
``Breakthrough Devices Program; Draft 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, or the Office of 
Communication, Outreach, and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your request.

FOR FURTHER INFORMATION CONTACT: Erin Cutts, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1625, Silver Spring, MD 20993-0002, 301-796-6307; 
or Stephen Ripley, Center for Biologics Evaluation and Research, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, 
Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is issuing this draft 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 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 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, clearance of a premarket notification 
(510(k)), and marketing authorization via the De Novo classification 
process, consistent with the Agency's statutory mission to protect and 
promote public health. No later than 1 year after the date of enactment 
of the Cures Act, FDA is required to issue this draft guidance, which 
sets forth the process by which a person may seek a Breakthrough Device 
designation, provides a template for designation requests, identifies 
the criteria that FDA will use in evaluating designation requests, and 
identifies the criteria and processes FDA will use to assign and train 
a team of staff to review breakthrough devices after designation has 
been granted. See section 515B(f) of the FD&C Act.
    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 grant 
priority to the review of associated Q-submissions, investigational 
device exemption (IDE) applications, PMAs, De Novo classification 
requests, and premarket notifications (510(k)s). In addition, for 
Breakthrough Devices subject to PMA, FDA may consider the amount of 
data that may be collected in the postmarket setting, rather than 
premarket, and the level of acceptable uncertainty 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 draft 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), both of 
which were intended to facilitate the development

[[Page 49375]]

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.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Breakthrough 
Devices Program; Draft 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 draft 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. Guidance 
documents are also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download 
an electronic copy of ``Breakthrough Devices Program'' 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 found in FDA regulations. 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 21 CFR part 807, subpart E have been 
approved under OMB control number 0910-0120; the collections of 
information for De Novo classification requests have been approved 
under OMB control number 0910-0844; the collections of information in 
21 CFR part 812 have been approved under OMB control number 0910-0078; 
the collections of information in 21 CFR part 814, subparts A through 
E, have been approved under OMB control number 0910-0231; the 
collections of information in 21 CFR part 814, subpart H, have been 
approved under OMB control number 0910-0332; the collections of 
information in 21 CFR part 820 have been approved under OMB control 
number 0910-0073; the collections of information in 21 CFR part 822 
have been approved under OMB control number 0910-0449; and the 
collections of information regarding ``Requests for Feedback on Medical 
Device Submissions'' have been approved under OMB control number 0910-
0756.

    Dated: October 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-23195 Filed 10-24-17; 8:45 am]
 BILLING CODE 4164-01-P