FDA Regulation of ECT Devices in Transition



GAITHERSBURG, MD. – A Food and Drug Administration advisory panel split on whether to recommend that electroconvulsive therapy devices be switched to a less stringent regulatory category when used to treat severe major depressive disorder. But the majority of the panel said that for other indications, ECT machines should be maintained at the level now used to regulate devices deemed as highest risk.

At the end of the 2-day meeting last month, about half of the FDA’s Neurological Devices Advisory Panel recommended that electroconvulsive therapy (ECT) devices be switched from a class III category to class II when used to treat severe depression. Class III devices, which have the most stringent regulatory controls, are used for medical devices such as replacement heart valves and silicone gel–filled breast implants. Class II devices, which are classified as "intermediate risk," include x-ray systems, gas analyzers, and surgical drapes. Currently, ECT devices are cleared for use by the FDA for treating severe depression (unipolar and bipolar), schizophrenia, bipolar manic (and mixed) states, schizoaffective disorder, schizophreniform disorder, and catatonia.

Under the Medical Devices Amendments of 1976, class III devices require manufacturers to submit a premarket approval application (PMA), which includes clinical trial data, to provide adequate evidence that the device is safe and effective for its intended use. But because ECT devices were on the market before 1976, they have been exempted from the approval process. Instead, ECT manufacturers have been required to show that the devices are substantially equivalent to a legally marketed device before they are cleared for marketing.

The FDA is in the process of developing regulations that will either reclassify ECT and other devices marketed before the amendments went into effect or keep them in the class III category. Keeping them in the class III category would require that the manufacturers submit PMAs for them to remain on the market. Reclassification into the intermediate risk (class II) category for devices would avoid requiring manufacturers to apply for approval but could require "special controls" to mitigate the associated risks of the device to "provide reasonable assurance" of their safety and effectiveness. Such controls could include postmarket surveillance, patient registries, and/or development and dissemination of guidelines, according to the FDA, which held the meeting to get feedback on how ECT devices should be classified for severe depression and the other indications cleared by the agency for treatment with ECT.

The panel supported labeling that would require physicians to monitor a patient’s cognitive status as part of the efforts to mitigate risk prior to undergoing ECT and throughout the course of treatment.

Class III or Class II?

Among the reasons cited by panelists supporting the class III category for severe depression were associated memory loss and the lack of long-term data. These panelists included the consumer and patient representatives on the panel, who were concerned about the lack of knowledge about long-term adverse effects associated with ECT. Dr. David Good, professor and chair of neurology, Pennsylvania State College, Hershey, said that despite responses in the public docket describing ECT as lifesaving, he leaned toward supporting class III status because of the absence of long-term data and evidence showing that ECT is associated with memory loss.

Those supporting a switch to the class II category agreed there was adequate evidence that ECT was effective and advocated the use of special controls to help mitigate the associated risks of ECT.

"It would be a mistake to even take the risk of leaving it at as a class III and the possibility that it may be removed from the market," said Dr. Wayne K. Goodman, professor and chairman of the department of psychiatry, Mount Sinai School of Medicine, New York. He pointed out that there is no alternative to ECT for acutely suicidal patients with treatment-resistant depression, for whom ECT is "literally, life saving. ... so to eliminate this option literally would be eliminating a lifeline to many patients." Dr. Goodman referred to what he believes is a disconnect between the strength of the published data on ECT and the clinical impressions of the effectiveness of ECT among psychiatrists like himself, and noted that about 20-25 years ago, "there was such a strong wealth of clinical impression that ECT is so efficacious, that we’ve skipped the step somewhere along the way of clinical trials that normally would convince a panel like this that we have adequate evidence for efficacy and safety."

Panel members also were asked to provide feedback on how the devices should be classified when used for treating schizophrenia, bipolar manic and mixed states, schizoaffective disorder, schizophreniform disorder, and catatonia. Most of the panel agreed that ECT devices remain in class III for schizophrenia, bipolar manic (and mixed) states, and schizoaffective disorder.


Next Article: