80 FR 22205 - Acceptance of Medical Device Clinical Data From Studies Conducted Outside the United States; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States; Draft Guidance for Industry and Food and Drug Administration Staff.'' This draft guidance articulates FDA's current policy of accepting scientifically valid clinical data obtained from foreign clinical studies in support of premarket submissions for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 This draft guidance is not final nor is it in effect at this time.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, Number 76 (Tuesday, April 21, 2015)]
[Notices]
[Pages 22205-22206]
From the Federal Register Online  [www.thefederalregister.org]
[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Outside the United States; Draft Guidance for Industry and Food and 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the availability of the draft guidance entitled ``Acceptance of Medical 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Draft Guidance for Industry and Food and Drug Administration Staff.'' 
This draft guidance articulates FDA's current policy of accepting 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 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