80 FR 22205 - Acceptance of Medical Device Clinical Data From Studies Conducted Outside the United States; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 76 (April 21, 2015)

Page Range		22205-22206
FR Document		2015-09176

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States; Draft Guidance for Industry and Food and Drug Administration Staff.'' This draft guidance articulates FDA's current policy of accepting scientifically valid clinical data obtained from foreign clinical studies in support of premarket submissions for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 This draft guidance is not final nor is it in effect at this time.

Federal Register, Volume 80 Issue 76 (Tuesday, April 21, 2015)

[Federal Register Volume 80, Number 76 (Tuesday, April 21, 2015)]
[Notices]
[Pages 22205-22206]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-09176]


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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Outside the United States; Draft Guidance for Industry and Food and 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.

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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the availability of the draft guidance entitled ``Acceptance of Medical 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Draft Guidance for Industry and Food and Drug Administration Staff.'' 
This draft guidance articulates FDA's current policy of accepting 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 http://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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://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 [email protected] 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 http://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 http://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

Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices 22205

meeting will be based on space transcript also will be available in either download from the Internet. See the
availability. hard copy or on CD–ROM upon SUPPLEMENTARY INFORMATION section for
If you wish to present at the meeting, submission of a Freedom of Information information on electronic access to the
please include your presentation request. Send written requests to the guidance. Submit written requests for a
materials along with your registration Division of Freedom of Information single hard copy of the draft guidance
information to GenericDrugPolicy@ (ELEM–1029), Food and Drug document entitled ‘‘Acceptance of
fda.hhs.gov by June 1, 2015. Early Administration, 12420 Parklawn Dr., Medical Device Clinical Data from
requests for oral presentations are Element Bldg., Rockville, MD 20857. Studies Conducted Outside the United
recommended due to possible space and States; Draft Guidance for Industry and
Dated: April 15, 2015.
time limitations. FDA will Food and Drug Administration Staff’’ to
Leslie Kux,
accommodate as many requests for oral the Office of the Center Director,
presentations as possible and will do so Associate Commissioner for Policy.
Guidance and Policy Development,
on a first-come, first-served basis. The [FR Doc. 2015–09091 Filed 4–20–15; 8:45 am]
Center for Devices and Radiological
time allotted for presentations may BILLING CODE 4164–01–P Health, Food and Drug Administration,
depend on the number of persons who 10903 New Hampshire Ave., Bldg. 66,
wish to speak. Those requesting to Rm. 5431, Silver Spring, MD 20993–
present will receive confirmation once DEPARTMENT OF HEALTH AND
0002 or the Office of Communication,
they have been accepted. If HUMAN SERVICES
Outreach and Development, Center for
presentations exceed time and space Biologics Evaluation and Research
Food and Drug Administration
limitations prior to the meeting, FDA (CBER), Food and Drug Administration,
will place a notice on http:// [Docket No. FDA–2015–D–0975] 10903 New Hampshire Avenue, Bldg.
www.fda.gov/gdufa. Onsite requests for 71, Rm. 3128, Silver Spring, MD 20993.
oral presentations on the day of the Acceptance of Medical Device Clinical Send one self-addressed adhesive label
meeting will be based on time and space Data From Studies Conducted Outside to assist that office in processing your
availability. If the entire meeting time is the United States; Draft Guidance for request.
not needed, FDA may end the public Industry and Food and Drug Submit electronic comments on the
meeting early. Administration Staff; Availability draft guidance to http://
If you need special accommodations AGENCY: Food and Drug Administration, www.regulations.gov. Submit written
because of a disability, please contact HHS. comments to the Division of Dockets
Connie Wisner or Kimberly Giordano Management (HFA–305), Food and Drug
ACTION: Notice.
(see FOR FURTHER INFORMATION CONTACT) Administration, 5630 Fishers Lane, Rm.
by June 8, 2015. SUMMARY: The Food and Drug 1061, Rockville, MD 20852. Identify
For those unable to attend in person, Administration (FDA or Agency) is comments with the docket number
FDA will provide a live Adobe Connect announcing the availability of the draft found in brackets in the heading of this
Webcast of the meeting. In order to guidance entitled ‘‘Acceptance of document.
connect to the Webcast, you must have Medical Device Clinical Data from FOR FURTHER INFORMATION CONTACT:
Adobe Connect. To join the meeting via Studies Conducted Outside the United Aaliyah Eaves-Leaños, Center for
the Adobe Connect Webcast, please go States; Draft Guidance for Industry and Devices and Radiological Health, Food
to: https://collaboration.fda.gov/gdufaii. Food and Drug Administration Staff.’’ and Drug Administration, 10903 New
IV. Comments This draft guidance articulates FDA’s Hampshire Ave., Bldg. 66, Rm. 5420,
current policy of accepting scientifically Silver Spring, MD 20993–0002, 301–
Regardless of participation at the valid clinical data obtained from foreign
public meeting, interested persons may 796–2948. For questions regarding this
clinical studies in support of premarket document concerning devices regulated
submit either electronic or written submissions for devices. The guidance
comments regarding this document. To by CBER, contact Stephen Ripley, 10903
describes special considerations that New Hampshire Ave., Bldg. 71, Rm.
ensure consideration, all comments apply when using such data, including
should be received by July 15, 2015. 7301, Silver Spring, MD 20993–0002,
applicability to populations within the 240–402–7911.
Submission of comments prior to the United States and study design issues
meeting is strongly encouraged. SUPPLEMENTARY INFORMATION:
and provides recommendations to assist
Submit electronic comments to I. Background
sponsors in ensuring their data are
http://www.regulations.gov. Submit
adequate under applicable FDA On July 9, 2012, the President signed
written comments to the Division of
standards to support approval or into law the Food and Drug
Dockets Management (HFA–305), Food
clearance of the device in the United Administration Safety and Innovation
and Drug Administration, 5630 Fishers
States. This guidance is not intended to Act (FDASIA), Public Law 112–144
Lane, rm. 1061, Rockville, MD 20852.
announce new policy, but to describe (2012), adding a new provision, section
Identify all comments with the docket
FDA’s existing approach to this topic. 569B, to the Federal Food, Drug, and
number found in the brackets in the
This draft guidance is not final nor is it Cosmetic Act (FD&C Act) codifying
heading of this document. Received
in effect at this time. FDA’s longstanding policy of accepting
comments may be seen in the Division
of Dockets Management between 9 a.m. DATES: Although you can comment on adequate, ethically-derived,
and 4 p.m., Monday through Friday. any guidance at any time (see 21 CFR scientifically valid data without regard
10.115(g)(5)), to ensure that the Agency to where a clinical study is conducted.
V. Transcripts
tkelley on DSK3SPTVN1PROD with NOTICES

considers your comment on this draft Sponsors may choose to conduct
Please be advised that as soon as a guidance before it begins work on the multinational clinical studies under a
transcript is available, it will be final version of the guidance, submit variety of scenarios. FDA acknowledges,
accessible at http://www.regulations.gov either electronic or written comments however, that certain challenges exist in
and http://www.fda.gov/gdufa. It may be on the draft guidance by July 20, 2015. using data derived from studies of
viewed at the Division of Dockets ADDRESSES: An electronic copy of the devices from sites from outside the
Management (see section IV). A guidance document is available for United States (OUS) to support an FDA

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Document Created: 2015-12-16 08:33:10
Document Modified: 2015-12-16 08:33:10

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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.
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.
FR Citation		80 FR 22205

80 FR 22205 - Acceptance of Medical Device Clinical Data From Studies Conducted Outside the United States; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 76 (April 21, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration