Document ID: FDA-2015-D-1777-0007
Agency: fda
Document Type: Notice
Title: Factors To Consider When Making Benefit-Risk Determinations for 
Medical Device Investigational Device Exemptions; Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators, and 
Food and Drug Administration Staff; Availability
Posted Date: 2017-01-13T05:00Z

[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Notices]
[Pages 4356-4358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00604]

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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; Guidance for 
Investigational Device Exemption Sponsors, Sponsor-Investigators, and 
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the guidance entitled ``Factors to Consider When 
Making Benefit-Risk Determinations for Medical Device Investigational 
Device Exemptions.'' The purpose of this guidance is to provide greater 
clarity for FDA staff and Investigational Device Exemptions (IDE) 
application sponsors and sponsor-investigators regarding the principal 
factors that the Agency considers when assessing the benefits and risks 
of IDE applications for human clinical study. The guidance also 
characterizes benefits in the context of investigational research, 
which includes direct benefits to the subjects and benefits to others.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your

[[Page 4357]]

comment, as well as any attachments, except for information submitted, 
marked and identified, as confidential, if submitted as detailed in 
``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-1777 for ``Factors to Consider When Making Benefit-Risk 
Determinations for Medical Device Investigational Device Exemptions.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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 guidance document entitled 
``Factors to Consider When Making Benefit-Risk Determinations for 
Medical Device Investigational Device Exemptions'' 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.

FOR FURTHER INFORMATION CONTACT: Karen Ulisney, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1545, Silver Spring, MD 20993-0002, 301-796-5513; 
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 ensure 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 
there 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, the 
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 and perspective on benefit 
may provide useful context during this assessment.
    In the Federal Register on June 18, 2015 (80 FR 34909), FDA 
announced the availability of the draft guidance and interested parties 
were requested to comment by September 16, 2015. FDA has considered all 
of the public comments received prior to finalizing this guidance.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Factors to Consider When Making Benefit-
Risk Determinations for Medical Device Investigational Device 
Exemptions.'' It does not establish any rights for any person and is 
not binding on FDA or the public. You can use an alternative approach 
if it satisfies the requirements of the applicable statutes and 
regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the 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.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryinformation/Guidances/default.htm or http://www.regulations.gov. 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 CDRH-Guidance@fda.hhs.gov 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 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-

[[Page 4358]]

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 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 56.115 (Institutional 
Review Board 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 part 56 (Institutional Review 
Boards) have been approved under OMB control number 0910-0755.

    Dated: January 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00604 Filed 1-12-17; 8:45 am]
 BILLING CODE 4164-01-P