Electroconvulsive Therapy Devices for Class II Intended Uses: Draft Guidance for Industry, Clinicians, and FDA Staff; Availability, 81330-81332 [2015-32591]
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Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Notices
factor that has increased the costs of the
evaluation is that OCSE is using the
grants management information system
developed for the grantees to monitor
their enrollment and service delivery,
which requires additional programming
and customized reports. Finally, OCSE
has asked for an internal memo
describing preliminary impact findings
which was not included in the FOA.
As a consequences of these
unanticipated costs, the $700,000
supplemental grant will be used for the
following activities: (1) Conduct the
day-to-day operation of the evaluation,
including all costs involved in ensuring
continued compliance with human
subject research requirements; (2)
conduct research and analyze
information from the multiple
implementation sites; (3) conduct the
baseline and follow-up surveys; (4)
maintain and provide evaluation-related
technical assistance to OCSE and the
grantees for the grants management
information system; and (5) complete an
internal memo describing interim
impact findings.
Statutory Authority: Section 1115 of the
Social Security Act authorizes funds for
experimental, pilot, or demonstration
projects that are likely to assist in promoting
the objectives of Part D of Title IV.
Christopher Beach,
Senior Grants Policy Specialist, Office of
Administration.
[FR Doc. 2015–32702 Filed 12–28–15; 8:45 am]
BILLING CODE 4184–42–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request;
Developmental Disabilities Protection
and Advocacy Statement of Goals and
Priorities
Administration for Community
Living, HHS.
ACTION: Notice.
AGENCY:
The Administration on
Intellectual and Developmental
Disabilities (AIDD), Administration for
Community Living (ACL) is announcing
an opportunity to comment on the
proposed collection of information by
the agency. Under the Paperwork
Reduction Act of 1995 (the PRA),
Federal agencies are required to publish
notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow for public
comment in response to the notice. This
notice collects comments on the
information collection requirements
relating to an existing collection:
Developmental Disabilities Protection
and Advocacy Statement of Goals and
Priorities (0985–0034).
DATES: Submit written comments on the
collection of information by January 28,
2016.
SUMMARY:
Submit written comments
on the collection of information by
email to OIRA_submission@
omb.eop.gov Attn: OMB Desk Officer for
ACL.
FOR FURTHER INFORMATION CONTACT:
Clare Barnett, Administration for
Community Living, Administration on
Intellectual and Developmental
Disabilities, Office of Program Support,
One Massachusetts Avenue NW., Room
4204, Washington, DC 20201, 202–357–
3426.
SUPPLEMENTARY INFORMATION: Federal
statute and regulation require each State
Protection and Advocacy (P&A) System
annually prepare for public comment a
Statement of Goals and Priorities (SGP)
for the P&A for Developmental
Disabilities (PADD) program for each
coming fiscal year. Following the
required public input for the coming
fiscal year, the P&A is required by
Federal statute and regulation to submit
the final version of the SGP to the
Administration on Intellectual and
Developmental Disabilities (AIDD).
AIDD reviews the SGP for compliance
and will aggregate the information in
the SGPs into a national profile of
programmatic emphasis for P&A
Systems in the coming year to provide
an overview of program direction, and
permit AIDD to track accomplishments
against goals and formulate areas of
technical assistance and compliance
with Federal requirements.
ACL estimates the burden of this
collection of information as follows:
ADDRESSES:
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses
per
respondent
Average
burden hours
per response
Total burden
hours
PADD SGP ......................................................................................................
57
1
16
912
Estimated Total Annual Burden
Hours: 2,508
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: December 22, 2015.
Kathy Greenlee,
Administrator & Assistant Secretary for
Aging.
Food and Drug Administration
[FR Doc. 2015–32667 Filed 12–28–15; 8:45 am]
asabaliauskas on DSK5VPTVN1PROD with NOTICES
BILLING CODE 4154–01–P
[Docket No. FDA–2014–D–1318]
Electroconvulsive Therapy Devices for
Class II Intended Uses: Draft Guidance
for Industry, Clinicians, and FDA Staff;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Electroconvulsive Therapy
SUMMARY:
VerDate Sep<11>2014
19:17 Dec 28, 2015
Jkt 238001
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
(ECT) Devices for Class II Intended
Uses: Draft Guidance for Industry,
Clinicians, and FDA Staff.’’ The purpose
of this guidance is to make
recommendations for 510(k)
submissions and complying with
special controls being proposed to
support reclassification of ECT Devices
into Class II (special controls) for severe
major depressive episode (MDE)
associated with Major Depressive
Disorder (MDD) or Bipolar Disorder
(BPD) in patients 18 years of age and
older who are treatment-resistant or
who require a rapid response due to the
severity of their psychiatric or medical
condition. This draft guidance is not
final nor is it in effect at this time.
E:\FR\FM\29DEN1.SGM
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Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Notices
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 March 28,
2016.
DATES:
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 ‘‘Electroconvulsive
Therapy (ECT) Devices for Class II
Intended Uses: Draft Guidance for
Industry, Clinicians, and FDA 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. You may submit
comments as follows:
ADDRESSES:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
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
VerDate Sep<11>2014
19:17 Dec 28, 2015
Jkt 238001
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–
2014–D–1318 for ‘‘Electroconvulsive
Therapy (ECT) Devices for Class II
Intended Uses: Draft Guidance for
Industry, Clinicians and FDA Staff.’’
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
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
81331
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Peter G. Como, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G242, Silver Spring,
MD 20993–0002, 301–796–6919.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance document
provides draft recommendations for
510(k) submissions and complying with
special controls being proposed to
support reclassification of ECT Devices
into Class II (special controls) for severe
MDE associated with MDD or BPD in
patients 18 years of age and older who
are treatment-resistant or who require a
rapid response due to the severity of
their psychiatric or medical condition.
An ECT device is an electrical device
used for treating severe psychiatric
disturbances by inducing in the patient
a major motor seizure by applying a
brief intense electrical current to the
patient’s head. This draft guidance is
being issued in conjunction with a
Federal Register notice announcing the
proposal to reclassify this device type
for this intended use. This guidance is
issued for comment purposes only.
FDA is issuing a proposed
administrative order to reclassify ECT
devices for the treatment of severe MDE
associated with MDD or BPD in patients
18 years of age or older who are
treatment-resistant or who require a
rapid response due to the severity of
their psychiatric or medical condition,
which are currently Class III devices,
into Class II (special controls) subject to
premarket notification. FDA is
proposing this reclassification under the
Federal Food, Drug and Cosmetic Act
(FD&C Act) based on new information
pertaining to the device. This guidance
is intended to provide recommendations
on how to comply with the special
controls proposed in 21 CFR
876.5540(b)(1) and indicate what
information is suggested for submission
to FDA in a 510(k) to demonstrate that
the special controls have been met.
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 ECT devices for Class II intended
uses. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
E:\FR\FM\29DEN1.SGM
29DEN1
81332
Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Notices
alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection contained in
FDA’s regulations on current good
manufacturing practice (CGMP) for
positron emission tomography (PET)
drugs.
SUMMARY:
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 ‘‘Electroconvulsive Therapy (ECT)
Devices for Class II Intended Uses: Draft
Guidance for Industry, Clinicians, and
FDA Staff’’ may send an email request
to CDRH-Guidance@fda.hhs.gov to
receive an electronic copy of the
document. Please use the document
number 1823 to identify the guidance
you are requesting.
Submit either electronic or
written comments on the collection of
information by February 29, 2016.
ADDRESSES: You may submit comments
as follows:
DATES:
Electronic Submissions
Food and Drug Administration
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’’).
[Docket No. FDA–2013–N–0242]
Written/Paper Submissions
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 collection of
information in 21 CFR part 807 subpart
E have been approved under OMB
control number 0910–0120; the
collection of information in 21 CFR 801
has been approved under OMB control
number 0910–0485; and the collection
of information in 21 CFR part 820 have
been approved under OMB control
number 0910–0073.
Dated: December 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–32591 Filed 12–28–15; 8:45 am]
BILLING CODE 4164–01–P
asabaliauskas on DSK5VPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Current Good
Manufacturing Practice for Positron
Emission Tomography Drugs
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
19:17 Dec 28, 2015
Jkt 238001
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
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
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–
2013–N–0242 for ‘‘Agency Information
Collection Activities: Proposed
Collection; Comment Request; Current
Good Manufacturing Practice for
Positron Emission Tomography Drugs.’’
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.
E:\FR\FM\29DEN1.SGM
29DEN1
]]>Agencies
[Federal Register Volume 80, Number 249 (Tuesday, December 29, 2015)]
[Notices]
[Pages 81330-81332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32591]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-1318]
Electroconvulsive Therapy Devices for Class II Intended Uses:
Draft Guidance for Industry, Clinicians, and FDA Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Electroconvulsive Therapy
(ECT) Devices for Class II Intended Uses: Draft Guidance for Industry,
Clinicians, and FDA Staff.'' The purpose of this guidance is to make
recommendations for 510(k) submissions and complying with special
controls being proposed to support reclassification of ECT Devices into
Class II (special controls) for severe major depressive episode (MDE)
associated with Major Depressive Disorder (MDD) or Bipolar Disorder
(BPD) in patients 18 years of age and older who are treatment-resistant
or who require a rapid response due to the severity of their
psychiatric or medical condition. This draft guidance is not final nor
is it in effect at this time.
[[Page 81331]]
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 March 28, 2016.
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
``Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses:
Draft Guidance for Industry, Clinicians, and FDA 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. 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-2014-D-1318 for ``Electroconvulsive Therapy (ECT) Devices for Class
II Intended Uses: Draft Guidance for Industry, Clinicians and FDA
Staff.'' 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.
FOR FURTHER INFORMATION CONTACT: Peter G. Como, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G242, Silver Spring, MD 20993-0002, 301-796-6919.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance document provides draft recommendations for
510(k) submissions and complying with special controls being proposed
to support reclassification of ECT Devices into Class II (special
controls) for severe MDE associated with MDD or BPD in patients 18
years of age and older who are treatment-resistant or who require a
rapid response due to the severity of their psychiatric or medical
condition. An ECT device is an electrical device used for treating
severe psychiatric disturbances by inducing in the patient a major
motor seizure by applying a brief intense electrical current to the
patient's head. This draft guidance is being issued in conjunction with
a Federal Register notice announcing the proposal to reclassify this
device type for this intended use. This guidance is issued for comment
purposes only.
FDA is issuing a proposed administrative order to reclassify ECT
devices for the treatment of severe MDE associated with MDD or BPD in
patients 18 years of age or older who are treatment-resistant or who
require a rapid response due to the severity of their psychiatric or
medical condition, which are currently Class III devices, into Class II
(special controls) subject to premarket notification. FDA is proposing
this reclassification under the Federal Food, Drug and Cosmetic Act
(FD&C Act) based on new information pertaining to the device. This
guidance is intended to provide recommendations on how to comply with
the special controls proposed in 21 CFR 876.5540(b)(1) and indicate
what information is suggested for submission to FDA in a 510(k) to
demonstrate that the special controls have been met.
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 ECT devices
for Class II intended uses. It does not create or confer any rights for
or on any person and does not operate to bind FDA or the public. An
[[Page 81332]]
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 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 ``Electroconvulsive Therapy
(ECT) Devices for Class II Intended Uses: Draft Guidance for Industry,
Clinicians, and FDA Staff'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document.
Please use the document number 1823 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
collection of information in 21 CFR part 807 subpart E have been
approved under OMB control number 0910-0120; the collection of
information in 21 CFR 801 has been approved under OMB control number
0910-0485; and the collection of information in 21 CFR part 820 have
been approved under OMB control number 0910-0073.
Dated: December 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32591 Filed 12-28-15; 8:45 am]
BILLING CODE 4164-01-P
