Breakthrough Devices Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 49373-49375 [2017-23195]
Download as PDF
<![CDATA[
sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices
level of risk. Clinically relevant DDIs
between an investigational drug and
other drugs should therefore: (1) Be
defined during drug development as
part of an adequate assessment of the
drug’s overall benefit/risk profile; (2) be
known at the time of the drug’s
approval; and (3) be communicated in
labeling. These two draft guidances are
intended to assist drug developers in the
planning and evaluation of DDI
potential during drug development. In
particular, the in vitro DDI guidance
focuses on in vitro experimental
approaches for evaluating metabolizing
enzyme- and transporter-based drug
interaction potential, and how to
extrapolate in vitro data to decide on the
need for clinical DDI studies. The
appendix of the in vitro DDI guidance
includes considerations in the choice of
in vitro experimental systems, key
issues regarding in vitro experimental
conditions, and a more detailed
explanation of model-based DDI
prediction strategies. If in vitro
assessments indicate the need to
conduct clinical DDI studies, sponsors
should consult the related clinical DDI
guidance. The clinical DDI guidance
focuses on clinical studies that evaluate
DDIs that alter a drug’s
pharmacokinetics by modulating the
effects of drug metabolizing enzymes
and/or transporters and advises
sponsors on the timing and design of the
clinical studies, interpretation of the
results, and options for DDI
management in patients. Together, the
two draft guidances describe a
systematic, risk-based approach to
evaluation and communication of DDIs.
In the Federal Register of February
21, 2012 (77 FR 9946), FDA announced
the availability of a revised draft
guidance entitled ‘‘Drug Interaction
Studies—Study Design, Data Analysis,
Implications for Dosing, and Labeling
Recommendations.’’ We received
comments on the 2012 draft guidance
and have considered these comments
while updating the information in the
two draft guidances. In addition, new
developments in the field have been
incorporated to reflect the Agency’s
current thinking.
The Agency decided to divide the
2012 draft guidance into two guidances
with one focusing on in vitro DDI
evaluation and the other focusing on
clinical DDI evaluation. We are
publishing the two draft guidances to
collect additional public comments.
These new draft guidances focus on
metabolism- and transporter-based drug
interactions. Other types of interactions,
e.g., drug-therapeutic protein
interactions and pH-dependent drug
interactions, are not included. Separate
VerDate Sep<11>2014
22:06 Oct 24, 2017
Jkt 244001
guidances will be developed to cover
other types of DDIs. In addition, a draft
guidance specific to Section 7 (Drug
Interactions) labeling will be developed
to delineate the communication of DDI
information in labeling.
These two draft guidances are being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). These draft guidances, when
finalized, will represent the Agency’s
current thinking on ‘‘In Vitro
Metabolism- and Transporter-Mediated
Drug-Drug Interaction Studies’’ and
‘‘Clinical Drug Interaction Studies—
Study Design, Data Analysis, and
Clinical Implications.’’ 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.
These guidances are not subject to
Executive Order 12866.
II. Paperwork Reduction Act of 1995
These draft guidances refer 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 314.50(d) have
been approved under OMB control
number 0910–0001.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: October 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–23102 Filed 10–24–17; 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; Draft
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
SUMMARY:
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
49373
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.
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.
DATES:
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
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.
E:\FR\FM\25OCN1.SGM
25OCN1
49374
Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
• 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
VerDate Sep<11>2014
22:06 Oct 24, 2017
Jkt 244001
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
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:
FOR FURTHER INFORMATION CONTACT:
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
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
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
E:\FR\FM\25OCN1.SGM
25OCN1
Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices
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.
sradovich on DSK3GMQ082PROD with NOTICES
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/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/default.htm or
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Breakthrough Devices Program’’ may
send an email request to CDRHGuidance@fda.hhs.gov 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
VerDate Sep<11>2014
22:06 Oct 24, 2017
Jkt 244001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0453]
Deciding When To Submit a 510(k) for
a Change to an Existing Device;
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 the
guidance entitled ‘‘Deciding When to
Submit a 510(k) for a Change to an
Existing Device.’’ FDA is issuing this
final guidance document to clarify when
a change in a legally marketed medical
device would require that a
manufacturer submit a premarket
notification (510(k)) to FDA. This
guidance document supersedes
‘‘Deciding When to Submit a 510(k) for
a Change to an Existing Device,’’ issued
January 10, 1997. FDA is correcting an
error in the docket number assigned to
the ‘‘Deciding When to Submit a 510(k)
for a Change to an Existing Device’’
notice of availability when it published
in the Federal Register (81 FR 52443,
August 8, 2016). The docket number
currently is FDA–2016–D–2021. FDA is
changing the docket number to FDA–
2011–D–0453. This action is
administrative in nature and is being
SUMMARY:
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
49375
taken to avoid any potential confusion
in the docket.
DATES: The announcement of the
guidance is published in the Federal
Register on October 25, 2017.
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–
2011–D–0453 for ‘‘Deciding When to
Submit a 510(k) for a Change to an
Existing Device.’’ 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.
E:\FR\FM\25OCN1.SGM
25OCN1
]]>Agencies
[Federal Register Volume 82, Number 205 (Wednesday, October 25, 2017)]
[Notices]
[Pages 49373-49375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23195]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.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 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
