FDA Lowers Risk Category for Some ECT Uses
Order Also Requires More Information for Other Uses
The US Food and Drug Administration (FDA) recently published a final order that requires manufacturers to file a premarket approval application for most uses of electroconvulsive therapy (ECT) devices.
The rule also downgrades the risk category—from higher risk (Class III) to moderate risk (Class II)—for ECT devices used for the treatment of catatonia or a severe major depressive episode associated with major depressive disorder or bipolar disorder in patients 13 and older who are treatment-resistant or require a rapid response treatment due to the severity of their condition.
“The safe use of ECT for treatment of these conditions has been well studied and is better understood than other uses,” the FDA stated. “Therefore, sufficient information exists to establish special controls that mitigate known risks and provide a reasonable assurance of safety and effectiveness for these two uses of ECT devices.”
The order was effective December 26, 2018. For treatment of catatonia or a severe major depressive episode associated with major depressive disorder or bipolar disorder, manufacturers will now need to submit information to the FDA demonstrating ECT devices comply with special controls. For all other indications, manufacturers must file the more rigorous premarket approval application.
“The final order requires ECT manufacturers to file a premarket approval application for all uses that are not being reclassified to class II, such as schizoaffective disorder and bipolar manic states, because the FDA is unable to identify sufficient information to establish special controls to provide a reasonable assurance of safety and effectiveness of ECT devices for such indications,” the FDA stated.
“This will give physicians more information on the safe and effective use of these devices and ultimately better protect patients,” said Carlos Peña, PhD, director of the division of neurological and physical medicine devices in the FDA Center for Devices and Radiological Health.
US Food and Drug Administration. Neurological devices; reclassification of electroconvulsive therapy devices; effective date of requirement for premarket approval for electroconvulsive therapy devices for certain specified intended uses. Federal Register. 2018;83(246):66103-66124.
FDA in brief: FDA takes action to ensure regulation of electroconvulsive therapy devices better protects patients, reflects current understanding of safety and effectiveness [press release]. Silver Spring, Maryland: US Food and Drug Administration; December 21, 2018.