Medical Devices: Neurological Devices; Electroconvulsive Therapy Device; Establishing a Public Docket

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 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.