
[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)]
[Notices]
[Pages 11807-11808]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04947]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0539]


Clinical Considerations for Investigational Device Exemptions for 
Neurological Devices Targeting Disease Progression and Clinical 
Outcomes; Draft Guidance for Industry and Food and Drug Administration 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the availability of the draft guidance entitled ``Clinical 
Considerations for Investigational Device Exemptions (IDEs) for 
Neurological Devices Targeting Disease Progression and Clinical 
Outcomes.'' The Center for Devices and Radiological Health (CDRH) 
developed this draft guidance to assist sponsors who intend to submit 
an IDE to the FDA to conduct clinical trials on medical devices 
targeting neurological disease progression and clinically meaningful 
patient centered outcomes. This draft guidance is not final nor is it 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by June 6, 2016.

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 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-2016-D-0539 for ``Clinical Considerations for Investigational 
Device Exemptions (IDEs) for Neurological Devices Targeting Disease 
Progression and Clinical Outcomes.'' 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 draft guidance document entitled 
``Clinical Considerations for Investigational Device Exemptions (IDEs) 
for Neurological Devices Targeting Disease Progression and Clinical 
Outcomes'' 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.

FOR FURTHER INFORMATION CONTACT: Carlos Pe[ntilde]a, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 2680, Silver Spring, MD 20993-0002, 301-
796-6610.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA believes that neurological devices intended to slow disease 
progression and improve clinical outcomes that are meaningful may 
represent a revolutionary option for patients. FDA developed this draft 
guidance to assist sponsors who intend to submit an IDE to the FDA to 
conduct clinical trials on medical devices targeting neurological 
disease progression and clinically meaningful patient centered 
outcomes. The draft guidance is intended to aid industry and FDA staff 
in considering the benefits and risks of medical devices that target 
either the cause or progression of the neurological disorder or 
condition such as Alzheimer's disease, Parkinson's

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Disease, or Primary Dystonia, rather than their symptoms. This draft 
guidance is intended to apply to neurological medical devices that are 
designed to slow, stop, or reverse the progression of disease and 
result in clinically meaningful patient outcomes. This draft guidance 
provides general study design considerations for clinical trials that 
investigate neurological devices using biological markers and clinical 
outcome assessments.

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 current thinking of FDA on ``Clinical 
Considerations for Investigational Device Exemptions (IDEs) for 
Neurological Devices Targeting Disease Progression and Clinical 
Outcomes.'' 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 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 ``Clinical Considerations for 
Investigational Device Exemptions (IDEs) for Neurological Devices 
Targeting Disease Progression and Clinical Outcomes'' may send an email 
request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of 
the document. Please use the document number 1500021 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 
parts 801 and 809 have been approved under OMB control number 0910-
0485; the collections of information in 21 CFR part 50 have been 
approved under OMB control number 0910-0755; and the collections of 
information in the guidance document entitled ``Request for Feedback on 
Medical Device Submissions: The Pre-submission Program and Meetings 
With Food and Drug Administration Staff'' have been approved under OMB 
control number 0910-0756.

    Dated: March 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04947 Filed 3-4-16; 8:45 am]
BILLING CODE 4164-01-P


