[Federal Register Volume 74, Number 174 (Thursday, September 10, 2009)]
[Notices]
[Pages 46607-46608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-21807]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0392]
Medical Devices: Neurological Devices; Electroconvulsive Therapy
Device; Establishing a Public Docket
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
opening of a public docket to receive information and comments
regarding the current classification process related to
electroconvulsive therapy devices (ECT). The current classification
process for this device pertains to the ``Order for Certain Class III
Devices; Submission of Safety and Effectiveness,'' published in the
Federal Register of April 9, 2009 (74 FR 16214). Under the Order, FDA
required manufacturers of certain Class III devices, including ECT, to
submit a summary of, and citation to, any information known or
otherwise available to them respecting such devices, including adverse
safety or effectiveness information which has not been submitted under
the Federal Food, Drug, and Cosmetic Act (the act). For each device
subject to the Order, FDA is reviewing the submitted information to
determine whether FDA should maintain the device as class III and
require the submission of a premarket approval application (PMA) or a
notice of completion of a product development protocol (PDP), or
whether FDA should reclassify the device into class II or class I. FDA
is now inviting interested persons to submit comments that relate to
the safety and effectiveness of ECT.
DATES: Submit written or electronic comments and information by
January 8, 2010.
ADDRESSES: Submit written comments and information to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
and information to http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Victor Krauthamer, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., W066-1106, Silver Spring, MD 20993, 301-796-2474.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of April 9, 2009 (74 FR 16214), FDA
published an ``Order for Certain Class III Devices; Submission of
Safety and Effectiveness Information'' (``515(i) Order''). Under this
Order, as mandated by section 515(i) of the act (21 U.S.C. 360e(i)),
FDA required manufacturers of certain class III devices that were in
commercial distribution before May 28, 1976, and devices found to be
substantially equivalent to them that were marketed on or after that
date, including ECT, to submit to FDA by August 7, 2009, a summary of,
and citation to, any information known, or otherwise available to them
respecting those devices including, adverse safety or effectiveness
data that had not been submitted under section 519 of the act (21
U.S.C. 360i). In addition, manufacturers were encouraged by FDA to
submit a summary of the information previously sent to FDA under
section 519 of the act. Currently, the agency is in the process of
reviewing the information that has been submitted by the manufacturers
subject to the 515(i) Order.
Based upon the review of this submitted information, FDA is
considering whether to issue a proposed rule requiring the device to
remain in class III, followed by the issuance of a regulation requiring
submission of a PMA or PDP, or to revise the classification of the
devices into class II, requiring the designation of special controls,
or into class I, requiring only general controls. In determining
whether to revise the classification of a device, or to require a
device to remain in class III, FDA will apply the criteria set forth in
section 513(a) of the act. If FDA decides to reclassify the device, FDA
must determine that general controls alone (class I) or general
controls plus special controls (class II) would provide reasonable
assurance of the safety and effectiveness of the device. FDA's proposed
classification of ECT devices will be subject to notice and comment
rulemaking to allow for additional public comment.
FDA has received a significant number of inquiries from members of
the public and the health care community in response to this order to
ECT manufacturers. In recognition of this significant public interest,
FDA is opening this docket to permit individuals other than
manufacturers to submit information related to the safety and
effectiveness of ECT. If individuals wish to report an adverse event
associated with the use of an ECT device, please use the MedWatch
Online Voluntary Reporting Form available at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm. FDA will
review information submitted through the MedWatch program prior to
making any changes to the classification of ECT devices.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic
[[Page 46608]]
comments or two paper copies of any mailed comments, except that
individuals may submit one paper copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: August 24, 2009.
Catherine M. Cook,
Associate Director for Regulations and Policy.
[FR Doc. E9-21807 Filed 9-9-09; 8:45 am]
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