(a) Identification. An electroconvulsive therapy device is a prescription device, including the pulse generator and its stimulation electrodes, 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.

(b) Classification.

(1) Class II (special controls) when the device is intended to treat catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition. The special controls for this device are:

(i) The technical parameters of the device, including waveform, output mode, pulse duration, frequency, train delivery, maximum charge and energy, and the type of impedance monitoring system must be fully characterized to ensure that the device performance characteristics are consistent with existing clinical performance data.

(ii) Non-clinical testing data must confirm the electrical characteristics of the output waveform.

(iii) Components of the device that come into human contact must be demonstrated to be biocompatible.

(iv) Performance data must demonstrate electrical and mechanical safety and the functioning of all safety features built into the device including the static and dynamic impedance monitoring system.

(v) Appropriate analysis/testing must validate electromagnetic compatibility.

(vi) Appropriate software verification, validation, and hazard analysis must be performed.

(vii) Performance data must demonstrate electrical performance, adhesive integrity, and physical and chemical stability of the stimulation electrodes.

(viii) The labeling for the device must include the following:

(A) Information related to generic adverse events associated with electroconvulsive therapy device (ECT) treatment;

(B) Instructions must contain the following specific recommendations to the user of the device:

(1) Conduct of pre-ECT medical and psychiatric assessment (including pertinent medical and psychiatric history, physical examination, anesthesia assessment, dental assessment, and other studies as clinically appropriate);

(2) Use of patient monitoring during the procedure;

(3) Use of general anesthesia and neuromuscular blocking agents;

(4) Use of mouth/dental protection during the procedure;

(5) Use of EEG monitoring until seizure termination;

(6) Instructions on electrode placement, including adequate skin preparation and use of conductive gel; and

(7) Cognitive status monitoring prior to beginning ECT and during the course of treatment via formal neuropsychological assessment for evaluating specific cognitive functions (e.g., orientation, attention, memory, executive function).

(C) Clinical training needed by users of the device;

(D) Information on the patient population in which the device is intended to be used;

(E) Information on how the device operates and the typical course of treatment;

(F) A detailed summary of the clinical testing, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device;

(G) A detailed summary of the device technical parameters;

(H) Where appropriate, validated methods and instructions for reprocessing of any reusable components;

(I) The following statement, prominently placed: “Warning: ECT device use may be associated with: disorientation, confusion, and memory problems”; and

(J) Absent performance data demonstrating a beneficial effect of longer term use, generally considered treatment in excess of 3 months, the following statement, prominently placed: “Warning: When used as intended this device provides short-term relief of symptoms. The long-term safety and effectiveness of ECT treatment has not been demonstrated.”

(ix) Patient labeling must be provided and include:

(A) Relevant contraindications, warnings, precautions;

(B) A summation of the clinical testing, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device;

(C) Information on how the device operates and the typical course of treatment;

(D) The potential benefits;

(E) Alternative treatments;

(F) The following statement, prominently placed: “Warning: ECT device use may be associated with: Disorientation, confusion, and memory problems”;

(G) Absent performance data demonstrating a beneficial effect of longer term use, generally considered treatment in excess of 3 months, the following statement, prominently placed: “Warning: When used as intended this device provides short-term relief of symptoms. The long-term safety and effectiveness of ECT treatment has not been demonstrated”; and

(H) The following statements on known risks of ECT, absent performance data demonstrating that these risks do not apply:

(1) ECT treatment may be associated with disorientation, confusion and memory loss, including short-term (anterograde) and long-term (autobiographical) memory loss following treatment. Based on the majority of clinical evidence, these side effects tend to go away within a few days to a few months after the last treatment with ECT. Although the incidence of permanent cognitive memory loss was not supported by the clinical literature, some patients have reported a permanent loss of memories of personal life events (i.e., autobiographical memory);

(2) Patients treated with ECT may experience manic symptoms (including euphoria and/or irritability, impulsivity, racing thoughts, distractibility, grandiosity, increased activity, talkativeness, and decreased need for sleep) or a worsening of the psychiatric symptoms they are being treated for; and

(3) The physical risks of ECT may include the following (in order of frequency of occurrence):

(i) Pain/somatic discomfort (including headache, muscle soreness, and nausea);

(ii) Skin burns;

(iii) Physical trauma (including fractures, contusions, injury from falls, dental and oral injury);

(iv) Prolonged or delayed onset seizures;

(v) Pulmonary complications (hypoxemia, hypoventilation, aspiration, upper-airway obstruction);

(vi) Cardiovascular complications (cardiac arrhythmias, heart attack, high or low blood pressure, and stroke); and

(vii) Death.

(2) Classification: Class III (premarket approval) for the following intended uses: schizophrenia, bipolar manic states, schizoaffective disorder, schizophreniform disorder, and catatonia or a severe MDE associated with MDD or BPD in:

(i) Patients under 13 years or

(ii) Patients 13 years and older who are not treatment-resistant or who do not require a rapid response due to the severity of their psychiatric or medical condition.

(c) Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before March 26, 2019, for any electroconvulsive therapy device with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976, or that has, on or before March 26, 2019, been found to be substantially equivalent to any electroconvulsive therapy device with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976. Any other electroconvulsive therapy device with an intended use described in paragraph (b)(2) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

[83 FR 66123, Dec. 26, 2018]