Document ID: FDA-2009-N-0392-0001
Agency: fda
Document Type: Notice
Title: Medical Devices: Neurological Devices; Electroconvulsive Therapy Device; Establishing a Public Docket
Posted Date: 2009-09-10T04:00Z

[Federal Register: September 10, 2009 (Volume 74, Number 174)]
[Notices]               
[Page 46607-46608]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10se09-67]                         

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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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