[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]
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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Draft Guidance for Industry, Clinicians, and FDA Staff; Availability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.
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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availability of the draft guidance entitled ``Electroconvulsive Therapy
(ECT) Devices for Class II Intended Uses: Draft Guidance for Industry,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 This draft guidance is not final nor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.
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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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 28, 2016.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requests for a single hard copy of the draft guidance document entitled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Draft Guidance for Industry, Clinicians, and FDA Staff'' to the Office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: 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-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
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.
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
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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. 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 [email protected] 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]
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