Acceptance of Medical Device Clinical Data From Studies Conducted Outside the United States; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 22205-22206 [2015-09176]
Download as PDF
Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices
meeting will be based on space
availability.
If you wish to present at the meeting,
please include your presentation
materials along with your registration
information to GenericDrugPolicy@
fda.hhs.gov by June 1, 2015. Early
requests for oral presentations are
recommended due to possible space and
time limitations. FDA will
accommodate as many requests for oral
presentations as possible and will do so
on a first-come, first-served basis. The
time allotted for presentations may
depend on the number of persons who
wish to speak. Those requesting to
present will receive confirmation once
they have been accepted. If
presentations exceed time and space
limitations prior to the meeting, FDA
will place a notice on https://
www.fda.gov/gdufa. Onsite requests for
oral presentations on the day of the
meeting will be based on time and space
availability. If the entire meeting time is
not needed, FDA may end the public
meeting early.
If you need special accommodations
because of a disability, please contact
Connie Wisner or Kimberly Giordano
(see FOR FURTHER INFORMATION CONTACT)
by June 8, 2015.
For those unable to attend in person,
FDA will provide a live Adobe Connect
Webcast of the meeting. In order to
connect to the Webcast, you must have
Adobe Connect. To join the meeting via
the Adobe Connect Webcast, please go
to: https://collaboration.fda.gov/gdufaii.
tkelley on DSK3SPTVN1PROD with NOTICES
IV. Comments
Regardless of participation at the
public meeting, interested persons may
submit either electronic or written
comments regarding this document. To
ensure consideration, all comments
should be received by July 15, 2015.
Submission of comments prior to the
meeting is strongly encouraged.
Submit electronic comments to
https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Identify all comments with the docket
number found in the brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
V. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://www.regulations.gov
and https://www.fda.gov/gdufa. It may be
viewed at the Division of Dockets
Management (see section IV). A
VerDate Sep<11>2014
18:07 Apr 20, 2015
Jkt 235001
transcript also will be available in either
hard copy or on CD–ROM upon
submission of a Freedom of Information
request. Send written requests to the
Division of Freedom of Information
(ELEM–1029), Food and Drug
Administration, 12420 Parklawn Dr.,
Element Bldg., Rockville, MD 20857.
Dated: April 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–09091 Filed 4–20–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–0975]
Acceptance of Medical Device Clinical
Data From Studies Conducted Outside
the United States; Draft Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Acceptance of
Medical Device Clinical Data from
Studies Conducted Outside the United
States; Draft Guidance for Industry and
Food and Drug Administration Staff.’’
This draft guidance articulates FDA’s
current policy of accepting scientifically
valid clinical data obtained from foreign
clinical studies in support of premarket
submissions for devices. The guidance
describes special considerations that
apply when using such data, including
applicability to populations within the
United States and study design issues
and provides recommendations to assist
sponsors in ensuring their data are
adequate under applicable FDA
standards to support approval or
clearance of the device in the United
States. This guidance is not intended to
announce new policy, but to describe
FDA’s existing approach to this topic.
This draft guidance is not final nor is it
in effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by July 20, 2015.
ADDRESSES: An electronic copy of the
guidance document is available for
SUMMARY:
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
22205
download from the Internet. See the
section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled ‘‘Acceptance of
Medical Device Clinical Data from
Studies Conducted Outside the United
States; 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
(CBER), Food and Drug Administration,
10903 New Hampshire Avenue, Bldg.
71, Rm. 3128, Silver Spring, MD 20993.
Send one self-addressed adhesive label
to assist that office in processing your
request.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
˜
Aaliyah Eaves-Leanos, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5420,
Silver Spring, MD 20993–0002, 301–
796–2948. For questions regarding this
document concerning devices regulated
by CBER, contact Stephen Ripley, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
SUPPLEMENTARY INFORMATION
I. Background
On July 9, 2012, the President signed
into law the Food and Drug
Administration Safety and Innovation
Act (FDASIA), Public Law 112–144
(2012), adding a new provision, section
569B, to the Federal Food, Drug, and
Cosmetic Act (FD&C Act) codifying
FDA’s longstanding policy of accepting
adequate, ethically-derived,
scientifically valid data without regard
to where a clinical study is conducted.
Sponsors may choose to conduct
multinational clinical studies under a
variety of scenarios. FDA acknowledges,
however, that certain challenges exist in
using data derived from studies of
devices from sites from outside the
United States (OUS) to support an FDA
E:\FR\FM\21APN1.SGM
21APN1
22206
Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices
marketing decision. These challenges
may include differences between the
OUS and U.S. clinical conditions,
regulatory requirements (including
human subject protections), and/or
study populations that may be sufficient
to affect the adequacy of the data for use
in establishing the safety and/or
effectiveness of the studied device. This
guidance focuses on considerations
sponsors of device submissions should
take into account when initiating, or
relying on previously collected data
from, an OUS clinical study to support
an Investigational Device Exemption,
Premarket Notification (510(k)), De
Novo Petition, Humanitarian Device
Exemption, or Premarket Approval
Application. This guidance also notes
other important considerations to take
into account when initiating or relying
on OUS data. FDA believes that
promoting greater clarity concerning
FDA’s use of foreign study data will
minimize the possibility for additional
or duplicative U.S. studies, further
efforts to harmonize global clinical trial
standards, and promote public health
and innovation.
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 Agency’s current thinking
on acceptance of clinical data from
foreign studies conducted OUS. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statute and regulations.
tkelley on DSK3SPTVN1PROD 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
Centers 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.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Acceptance of Medical Device
Clinical Data from Studies Conducted
Outside the United States; Draft
Guidance for Industry and Food and
Drug Administration Staff’’ may send an
email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number 1741 to identify the
guidance you are requesting.
VerDate Sep<11>2014
18:07 Apr 20, 2015
Jkt 235001
IV. Paperwork Reduction Act of 1995
This draft guidance refers to currently
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 parts 50 and 56 have been
approved under OMB control number
0910–0755; the collections of
information in 21 CFR part 601 have
been approved under OMB control
number 0910–0338; the collections of
information in 21 CFR parts 801 and
809 have been approved under OMB
control number 0910–0485; the
collections of information in 21 CFR
part 807, subpart E, have been approved
under OMB control number 0910–0120;
the collections of information in 21 CFR
part 812 has been approved under OMB
control number 0910–0078; the
collections of information in 21 CFR
part 814 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;
and the collections of information in 21
CFR part 820 have been approved under
OMB control number 0910–0073.
[FR Doc. 2015–09176 Filed 4–20–15; 8:45 am]
made of the following National
Advisory body scheduled to meet
during the month of May 2015.
The National Advisory Committee on
Rural Health and Human Services will
convene its seventy seventh meeting in
the time and place specified below:
Name: National Advisory Committee
on Rural Health and Human Services.
Dates and Time: May 27, 2015, 8:45
a.m.—5:00 p.m.; May 28, 2015, 8:30
a.m.—5:15 p.m.; May 29, 2015, 8:30
a.m.—11:00 a.m.
Place: Natural Bridge State Park, 2135
Natural Bridge Rd, Slade, KY 40376,
(606) 663–2214.
Status: The meeting will be open to
the public.
Purpose: The National Advisory
Committee on Rural Health and Human
Services provides counsel and
recommendations to the Secretary with
respect to the delivery, research,
development, and administration of
health and human services in rural
areas.
Agenda: Wednesday morning, at 8:45
a.m., the meeting will be called to order
by the Chairperson of the Committee:
The Honorable Ronnie Musgrove. The
Committee will examine the issue of an
increasing difference between life
expectancy among the urban and rural
populations of the United States. The
day will conclude with a period of
public comment at approximately 4:45
p.m.
Thursday morning at approximately
8:30 a.m., the Committee will break into
Subcommittees and depart for site
visits. Subcommittees will visit the
Center of Excellence in Rural Health in
Hazard, Kentucky, and the Marcum &
Wallace Memorial Hospital in Irvine,
Kentucky. The day will conclude at the
Natural Bridge State Park with a period
of public comment at approximately
5:00 p.m.
Friday morning at 8:30 a.m., the
Committee will meet to summarize key
findings and develop a work plan for
the next quarter and the following
meeting.
BILLING CODE 4164–01–P
FOR FURTHER INFORMATION CONTACT:
V. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: April 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Committee on Rural
Health and Human Services; Notice of
Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), announcement is
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
Steve Hirsch, MSLS, Executive
Secretary, National Advisory Committee
on Rural Health and Human Services,
Health Resources and Services
Administration, Parklawn Building,
17W29–C, 5600 Fishers Lane, Rockville,
MD 20857, Telephone (301) 443–0835,
Fax (301) 443–2803.
Persons interested in attending any
portion of the meeting should contact
Catherine Fontenot at the Federal Office
of Rural Health Policy (FORHP) via
telephone at (301) 945–0897 or by email
at cfontenot@hrsa.gov. The Committee
E:\FR\FM\21APN1.SGM
21APN1
Agencies
[Federal Register Volume 80, Number 76 (Tuesday, April 21, 2015)]
[Notices]
[Pages 22205-22206]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-09176]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-0975]
Acceptance of Medical Device Clinical Data From Studies Conducted
Outside the United States; Draft Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Acceptance of Medical
Device Clinical Data from Studies Conducted Outside the United States;
Draft Guidance for Industry and Food and Drug Administration Staff.''
This draft guidance articulates FDA's current policy of accepting
scientifically valid clinical data obtained from foreign clinical
studies in support of premarket submissions for devices. The guidance
describes special considerations that apply when using such data,
including applicability to populations within the United States and
study design issues and provides recommendations to assist sponsors in
ensuring their data are adequate under applicable FDA standards to
support approval or clearance of the device in the United States. This
guidance is not intended to announce new policy, but to describe FDA's
existing approach to this topic. This draft guidance is not final nor
is it in effect at this time.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by July 20, 2015.
ADDRESSES: 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
``Acceptance of Medical Device Clinical Data from Studies Conducted
Outside the United States; 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 (CBER), Food and Drug Administration, 10903 New
Hampshire Avenue, Bldg. 71, Rm. 3128, Silver Spring, MD 20993. Send one
self-addressed adhesive label to assist that office in processing your
request.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Aaliyah Eaves-Lea[ntilde]os, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5420, Silver Spring, MD 20993-
0002, 301-796-2948. For questions regarding this document concerning
devices regulated by CBER, contact Stephen Ripley, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2012, the President signed into law the Food and Drug
Administration Safety and Innovation Act (FDASIA), Public Law 112-144
(2012), adding a new provision, section 569B, to the Federal Food,
Drug, and Cosmetic Act (FD&C Act) codifying FDA's longstanding policy
of accepting adequate, ethically-derived, scientifically valid data
without regard to where a clinical study is conducted. Sponsors may
choose to conduct multinational clinical studies under a variety of
scenarios. FDA acknowledges, however, that certain challenges exist in
using data derived from studies of devices from sites from outside the
United States (OUS) to support an FDA
[[Page 22206]]
marketing decision. These challenges may include differences between
the OUS and U.S. clinical conditions, regulatory requirements
(including human subject protections), and/or study populations that
may be sufficient to affect the adequacy of the data for use in
establishing the safety and/or effectiveness of the studied device.
This guidance focuses on considerations sponsors of device submissions
should take into account when initiating, or relying on previously
collected data from, an OUS clinical study to support an
Investigational Device Exemption, Premarket Notification (510(k)), De
Novo Petition, Humanitarian Device Exemption, or Premarket Approval
Application. This guidance also notes other important considerations to
take into account when initiating or relying on OUS data. FDA believes
that promoting greater clarity concerning FDA's use of foreign study
data will minimize the possibility for additional or duplicative U.S.
studies, further efforts to harmonize global clinical trial standards,
and promote public health and innovation.
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 Agency's current thinking on acceptance
of clinical data from foreign studies conducted OUS. It does not create
or confer any rights for or on any person and does not operate to bind
FDA or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statute and regulations.
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 Centers 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.regulations.gov. Persons
unable to download an electronic copy of ``Acceptance of Medical Device
Clinical Data from Studies Conducted Outside the United States; Draft
Guidance for Industry and Food and Drug Administration Staff'' may send
an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic
copy of the document. Please use the document number 1741 to identify
the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to currently 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 parts 50 and 56 have been approved
under OMB control number 0910-0755; the collections of information in
21 CFR part 601 have been approved under OMB control number 0910-0338;
the collections of information in 21 CFR parts 801 and 809 have been
approved under OMB control number 0910-0485; the collections of
information in 21 CFR part 807, subpart E, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
812 has been approved under OMB control number 0910-0078; the
collections of information in 21 CFR part 814 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; and the collections of information in 21 CFR part 820 have been
approved under OMB control number 0910-0073.
V. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
Dated: April 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-09176 Filed 4-20-15; 8:45 am]
BILLING CODE 4164-01-P