[Federal Register Volume 79, Number 74 (Thursday, April 17, 2014)]
[Notices]
[Pages 21776-21777]
[FR Doc No: 2014-08710]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0331]

Live Case Presentations During Investigational Device Exemption
Clinical Trials; Draft Guidance for Institutional Review Boards,
Industry, Investigators, 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) is announcing the
availability of the draft guidance entitled ``Live Case Presentations
During Investigational Device Exemption (IDE) Clinical Trials: Draft
Guidance for Institutional Review Boards, Industry, Investigators, and
Food and Drug Administration Staff.'' This guidance is intended, in
part, to improve the quality of information submitted by sponsors in an
IDE application or supplement to an IDE application and to ensure
consistency in the review of those submissions. This draft guidance is
intended to clarify FDA's regulations and policies regarding live case

presentations using unapproved or uncleared investigational devices in
the United States. This draft guidance is not final nor is it in effect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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by July 16, 2014.

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requests for a single hard copy of the draft guidance document entitled
``Live Case Presentations During Investigational Device Exemption (IDE)
Clinical Trials: Draft Guidance for Institutional Review Boards,
Industry, Investigators, 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. 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: Sheila Brown, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1651, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Requests for live case presentations have been submitted to the
Agency as multiple supplements to an approved IDE application as either
protocol deviations, changes to the investigational plan, or study
expansion requests. Live case presentations have not generally been
prospectively identified and described as components of the overall
study design in original IDE applications.
    Although it is expected that very few investigations conducted
under an IDE will have the need for live case presentations, FDA has
seen an increase in the number of requests for certain investigations
to conduct live case presentations. Live case presentations may
increase awareness of the study for potential investigators and
facilitate the recruitment of subjects. Increased awareness of the IDE
clinical study by other health care professionals resulting from a live
case presentation might accelerate enrollment of eligible subjects
which, in turn, may lead to new therapies being made available sooner.
However, because of concerns related to human subject protection and
uncertainty about potential differences between outcomes of subjects
participating in live case presentations compared to subjects not
participating in live case presentations, this guidance was developed
for institutional review boards, review staff, the regulated industry
and clinical community.

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 live case
presentations during IDE clinical trials. 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 Center 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 ``Live Case Presentations
During Investigational Device Exemption (IDE) Clinical Trials: Draft
Guidance for Institutional Review Boards, Industry, Investigators, and
Food and Drug Administration Staff,'' may send an email request to
<EMAIL_ADDRESS>to receive an electronic copy of the
document. Please use the document number 1736 to identify the guidance
you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft 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 812 have been approved under
OMB control number 0910-0078.

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 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-08710 Filed 4-16-14; 8:45 am]
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