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for Investigational Device Exemptions for Neurological Devices Targeting Disease Progression and Clinical Outcomes; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 11807-11808 [2016-04947]
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Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Notices
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Outcomes; Draft Guidance for Industry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.
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announcing the availability of the draft
guidance entitled ‘‘Clinical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Health (CDRH) developed this draft
guidance to assist sponsors who intend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 This draft
guidance is not final nor is it in effect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considers your comment of this draft
guidance before it begins work on the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on the draft guidance by June 6, 2016.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:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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
VerDate Sep<11>2014
18:37 Mar 04, 2016
Jkt 238001
comments, that information will be
posted on https://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
https://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 https://
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’’
PO 00000
Frm 00070
Fmt 4703
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11807
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: https://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 https://
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 Pena, 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
E:\FR\FM\07MRN1.SGM
07MRN1
11808
Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Notices
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.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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 https://www.fda.gov/ MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://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
VerDate Sep<11>2014
18:37 Mar 04, 2016
Jkt 238001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–0768]
Donor Screening Recommendations
To Reduce the Risk of Transmission of
Zika Virus by Human Cells, Tissues,
and Cellular and Tissue-Based
Products; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
document entitled ‘‘Donor Screening
Recommendations to Reduce the Risk of
Transmission of Zika Virus by Human
Cells, Tissues, and Cellular and TissueBased Products; Guidance for Industry.’’
The guidance document provides
establishments that make donor
eligibility (DE) determinations for
donors of human cells, tissues, and
cellular and tissue-based products
(HCT/Ps) with recommendations for
screening donors for evidence of, and
risk factors for, infection with Zika virus
(ZIKV). The guidance identifies ZIKV as
a relevant communicable disease agent
or disease (RCDAD) and adds to
recommendations contained in the
guidance entitled ‘‘Eligibility
Determination for Donors of Human
Cells, Tissues, and Cellular and TissueBased Products (HCT/Ps)’’ dated August
2007.
DATES: The Agency is soliciting public
comment, but is implementing this
guidance immediately because the
Agency has determined that prior public
participation is not feasible or
appropriate. Submit either electronic or
written comments on Agency guidances
at any time.
SUMMARY:
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
ADDRESSES:
You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://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–0545 for ‘‘Donor Screening
Recommendations to Reduce the Risk of
Transmission of Zika Virus by Human
Cells, Tissues, and Cellular and TissueBased Products; Guidance for Industry.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://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
E:\FR\FM\07MRN1.SGM
07MRN1
]]>Agencies
[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]
[[Page 11807]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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 https://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 https://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: https://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 https://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
[[Page 11808]]
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 https://www.fda.gov/ MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://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
