[Federal Register Volume 80, Number 117 (Thursday, June 18, 2015)]
[Notices]
[Pages 34909-34910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14982]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1777]


Factors To Consider When Making Benefit-Risk Determinations for 
Medical Device Investigational Device Exemptions; Draft Guidance for 
Investigational Device Exemption Sponsors, Sponsor-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availability of the draft guidance entitled ``Factors to Consider When 
Making Benefit-Risk Determinations for Medical Device Investigational 
Device Exemptions (IDEs).'' The purpose of this draft guidance is to 
provide greater clarity for FDA staff and IDE sponsors and sponsor-
investigators regarding the principal factors that FDA considers when 
assessing the benefits and risks of IDE applications for human clinical 
study. The draft guidance also characterizes benefits in the context of 
investigational research, which includes direct benefits to the 
subjects and benefits to others (to the extent they are indirect 
benefits to subjects or reflect the importance of knowledge to be 
gained). This draft guidance is not final nor is it in effect at this 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 of 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 16, 2015.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requests for a single hard copy of the draft guidance entitled 
``Factors to Consider When Making Benefit-Risk Determinations for 
Medical Device Investigational Device Exemptions (IDEs)'' 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.
    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: Sugato De, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5435, Silver Spring, MD 20993-0002, 301-796-6270; 
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, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    A primary goal of this guidance is to clarify the factors that FDA 
considers when assessing risks and anticipated benefits for IDE 
studies, and how uncertainty may be offset by a variety of risk 
mitigation measures that can assure appropriate patient and participant 
protections in investigational research settings. At earlier stages of 
device development, FDA considers appropriate mitigation measures for 
anticipated possible risks and unanticipated risks, whereas in later 
stages, risk mitigation focuses increasingly on the most probable 
risks. Another important goal of this guidance is to characterize 
benefits in the context of investigational research, which includes 
direct benefits to the subjects and benefits to others (to the extent 
they are indirect benefits to subjects or reflect the importance of 
knowledge to be gained).
    As with the benefit-risk framework for evaluating marketing 
applications, FDA assessment of benefits and risks for an IDE 
application takes into account the contextual setting in which the 
study is being proposed, including but not limited to characterization 
of the disease or condition being treated or diagnosed, the 
availability of alternative treatments or diagnostics, and the risks 
associated with them. When available, information characterizing 
subject tolerance for risk

[[Page 34910]]

and perspective on benefit may provide useful context during this 
assessment.
    FDA believes use of this benefit-risk framework in an IDE 
application will facilitate the incorporation of evidence and knowledge 
from different domains--clinical, nonclinical, and patient--to support 
a comprehensive, balanced decision-making approach. FDA envisions this 
will facilitate a common understanding between FDA and sponsors/
sponsor-investigators by highlighting which factors are critical in the 
benefit-risk assessment for a specific application, and clearly 
explaining how these factors influence a regulatory decision. FDA also 
believes implementation of this guidance document will improve the 
predictability, consistency, and transparency of the review process for 
IDE applications.

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 ``Factors to 
Consider When Making Benefit-Risk Determinations for Medical Device 
Investigational Device Exemptions (IDEs).'' 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 or from CBER 
at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to 
download an electronic copy of ``Factors to Consider When Making 
Benefit-Risk Determinations for Medical Device Investigational Device 
Exemptions'' may send an email request to [email protected] to 
receive an electronic copy of the document. Please use the document 
number 1783 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; the collections of information in 21 CFR 
part 50.23 (Exception from general requirements for informed consent) 
have been approved under OMB control number 0910-0586; the collections 
of information in 21 CFR part 56.115 (IRB records) have been approved 
under OMB control number 0910-0130; and the collections of information 
in 21 CFR part 50, subpart B (Informed Consent of Human Subjects) and 
56 (Institutional Review Boards) have been approved under OMB control 
number 0910-0755.

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: June 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14982 Filed 6-17-15; 8:45 am]
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