The FDA is seeking stakeholder feedback on a proposal to reclassify electroconvulsive therapy devices from Class 3 to Class 2 for treating severe major depressive episodes associated with major depressive or bipolar disorder.
The reclassification would apply to patients 18 and older who are treatment-resistant or who require a rapid response due the severity of their condition, according to a proposed administrative order.
In separate draft guidance, the FDA says it also is proposing to require that sponsors identify technical parameters — including waveform, output mode, pulse duration, frequency, train delivery, maximum charge and energy and the type of impedance monitoring system necessary to characterize and compare the device performance.
In addition, the proposal would require that nonclinical testing confirm the electrical characteristics of the output waveform. Companies also would be required to perform appropriate software verification, validation and hazard analysis.
The FDA also is proposing the filing of a premarket approval application for ECT devices for certain specified intended uses. Sponsors would be required to submit a PMA application within 90 days after a final order is issued.
In general, the reclassification as proposed is not popular, according to submissions in 2009 public docket. Roughly 80 percent of 3,000 respondents opposed reclassification, with the majority citing adverse events from ECT treatment, including memory adverse events, other cognitive complaints, brain damage and death.
The FDA says the proposed special controls can effectively mitigate health risks, based on findings from an agency review that included examining the results of more than 60 randomized, controlled clinical trials. These studies evaluated ECT against either placebo or antidepressant therapy.